· 2018. 5. 21. · confidential: for review only effectiveness of text message-based diabetes...

Confidential: For Review Only

Effectiveness of text message-based diabetes self-

management support programme (SMS4BG): A randomised controlled trial

Journal: BMJ

Manuscript ID BMJ.2017.042433.R2

Article Type: Research

BMJ Journal: BMJ

Date Submitted by the Author: 05-Apr-2018

Complete List of Authors: Dobson, Rosie; University of Auckland, National Institute for Health Innovation Whittaker, Robyn; University of Auckland, National Institute for Health Innovation; Waitemata District Health Board Jiang, Yannan; University of Auckland, Natioanl Institute for Health Innovation Maddison, Ralph; Deakin University, Institute for Physical Activity and Nutrition; University of Auckland, National Institute for Health Innovation Shepherd, Matthew; The University of Auckland, School of Counselling, Human Services and Social Work, Faculty of Education McNamara, Catherine; Waitemata District Health Board, Diabetes Service Cutfield, Richard; Waitemata District Health Board, Diabetes Service

Khanolkar, Manish; Auckland District Health Board, Auckland Diabetes Service Murphy, R.; University of Auckland, Department of Medicine; Auckland District Health Board, Auckland Diabetes Service

Keywords: mHealth, Diabetes mellitus, Text message, Mobile phone, SMS, Self-management

https://mc.manuscriptcentral.com/bmj

BMJ


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Table 1: Description of the SMS4BG modules and example text messages

Module Description Example messages

Core module Two messages per week providing general motivation and support for diabetes management. Available in 3 versions: - Māori - Pacific - Non-Māori/Non-Pacific

SMS4BG: Kia ora. Control of your glucose levels involves eating the right kai, exercise & taking your medication. Your whānau, doctor & nurse can help you

SMS4BG: Talofa [name]. by managing your diabetes well (including eating well and exercising) you can show your family that diabetes can be controlled

SMS4BG: There is no quick fix to diabetes but with good management it will have less impact on your life and leave you more time to do the things you enjoy

Insulin module One educational text message per week around insulin management and hypos for people receiving insulin

SMS4BG: Keep unopened insulin in the fridge. Don’t use insulin that has changed colour, is lumpy, expired, cracked or leaking, or has been frozen or too hot

Young adult module

One message per week around managing diabetes in the context or work/school and social situations. Designed for people aged 16-24 years

SMS4BG: Unsure whether to tell your friends/boyfriend/girlfriend about diabetes? This can be tough but people who care about you will want to know & support you

Smoking cessation module

One message per month encouraging participants to consider quitting smoking and providing details of services for support. Designed for people who are current smokers.

SMS4BG: [hi] [name]. Good management of your diabetes & your future health includes not smoking, call Quitline on 0800 778 778 for support

Lifestyle behaviour modules

Up to 4 messages per week encouraging participants to set a lifestyle goal and supporting them to work towards this goal. Participants can receive one of these modules at a time. The three lifestyle modules are: Healthy eating, Exercise, and Stress and mood.

SMS4BG: Healthy eating is an important part of your diabetes treatment and it will help you in controlling your blood glucose levels

SMS4BG: If you are too tired to exercise at the end of the day, try waking up early & doing your exercise in the morning. It will energize you for the day

Blood glucose monitoring

Reminders to test blood glucose, sent at a frequency selected by the individual, for which they are encouraged to respond by reply text message with their blood sugar readings. Also informational messages around managing hypos.

SMS4BG: [hi] [name]. Make sure you have fun activities scheduled regularly. Doing something enjoyable helps reduce stress & improves mood

SMS4BG: [hi] [name]. Just a reminder it is time to check your blood glucose. Reply with the result

If valid response received to reminder, “SMS4BG: Thank you for sending your result”

Foot care module Reminders and motivational messages supporting engagement in foot care. Designed for those that are high risk or have active foot disease.

SMS4BG: Hypoglycaemia (hypos) are when your blood glucose drops too low (i.e. less than 4mmol/L). If this happens take something with sugar immediately

Cardiovascular check reminder

Reminder to engage in a yearly cardiovascular assessment

SMS4BG: Looking after your feet will help to prevent issues in the future.

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Check your feet daily & contact your doctor, nurse or podiatrist if there are changes

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Confidential: For Review OnlySTUDY PROTOCOL Open Access

Text message-based diabetes self-management support (SMS4BG): studyprotocol for a randomised controlled trialRosie Dobson1* , Robyn Whittaker1,2, Yannan Jiang1, Matthew Shepherd3, Ralph Maddison1, Karen Carter1,Richard Cutfield2, Catherine McNamara2, Manish Khanolkar4 and Rinki Murphy4,5

Abstract

Background: Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of healthservices internationally. Interventions to support patients to effectively self-manage their condition have the potentialto reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-managementsupport allows for patient-centred care at the frequency and intensity that patients desire from outside the clinicenvironment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based interventionfor supporting people with diabetes to improve self-management behaviours and achieve better glycaemic controland is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims toassess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlinesthe rationale and methods of the trial.

Methods/design: A two-arm, parallel, randomised controlled trial will be conducted across New Zealand healthdistricts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based andindividually tailored automated text message-based diabetes self-management support programme (intervention) inaddition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours,diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost informationand healthcare utilisation will also be collected as well as intervention satisfaction and interaction.

Discussion: This study will provide information on the effectiveness of a text message-based self-managementsupport tool for people with diabetes. If found to be effective it has the potential to provide individualised support topeople with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment.

Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12614001232628.

Keywords: mHealth, Diabetes mellitus, Text message, Mobile phone, SMS, Self-management

BackgroundAddressing increasing diabetes prevalence, its associatedmorbidity and health inequalities, is a current priority inNew Zealand and internationally [1–4]. The burden ofdiabetes is greater in indigenous peoples [1] with higherdisease prevalence and poorer outcomes seen in Māori[5, 6]. Good diabetes self-management, including glucose

monitoring, engaging in health behaviours, insulin ad-ministration, and healthcare provider contact, is associ-ated with improved glycaemic control, and even smallimprovements in glycaemic control are associated withreduction in costly and debilitating long-term compli-cations [7–12].Mobile phones are ubiquitous, with increasing owner-

ship and use across hard-to-reach populations [13, 14].Text message (short message service, SMS) volumes haveremained high over recent years with nearly 14 billionSMS messages sent in New Zealand in the year ending

* Correspondence: [email protected] Institute for Health Innovation, University of Auckland, Private Bag92019, Auckland 1142, New ZealandFull list of author information is available at the end of the article

© 2016 Dobson et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Dobson et al. Trials (2016) 17:179 DOI 10.1186/s13063-016-1305-5

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http://crossmark.crossref.org/dialog/?doi=10.1186/s13063-016-1305-5&domain=pdf

http://orcid.org/0000-0003-0122-1000

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367369

mailto:[email protected]

http://creativecommons.org/licenses/by/4.0/

http://creativecommons.org/publicdomain/zero/1.0/

Confidential: For Review OnlyJune 2012 [15]. Mobile health (mHealth) is the use ofmobile devices, including mobile phones, to deliverhealth services and information [16]. Mobile phoneshave been used effectively to support healthy behaviourchange and disease management [17–21], and offer anideal way of providing patient-centred care at the fre-quency and intensity that patients desire. In additionthere is potential for mobile phones to provide an ef-fective way of providing support to patients in ruraland remote areas where healthcare provider contactmay be less accessible [22, 23].There is a growing body of evidence supporting the

use of mobile phones in the management of diabetes[24–26], with previous studies showing positive impactson glycaemic control [25, 27], patient satisfaction withhealthcare [25], healthcare costs [25], self-efficacy [28],and self-management behaviours, e.g. adherence and bloodglucose monitoring [28–30]. Although promising, manyprevious studies have lacked sufficient sample sizes, wereof insufficient duration, or interventions lacked theoreticalgrounding. Learnings has identify that for this type ofintervention to be successful it needs to be theoreticallybased [19, 31], individually tailored [22, 32–35], and toprovide individual choice to increase patients’ sense ofcontrol [36].In light of the increasing prevalence of diabetes in New

Zealand, as well as increasing mobile phone penetration,we hypothesise that mobile-based tools are important op-tions for self-management support in this population. Amobile phone-based text messaging programme designedto enhance self-management support for people with dia-betes (SMS4BG: Self-Management Support for Blood Glu-cose) has been developed and piloted [37]. Developmentof the SMS4BG followed the mHealth Development andEvaluation framework [38], with a focus on implementa-tion, use of behavioural change theory, and engagement ofkey stakeholders including clinicians and patients. Con-ceptualisation, formative research and pretesting, includ-ing a pilot study, have been previously reported [37, 39].SMS4BG was developed by a multidisciplinary team

including public health and mHealth experts, psycholo-gists, diabetes nurse specialists, a Māori advisory group,with review and input from diabetes specialists and pri-mary care teams. The intervention is grounded in behav-iour change theory to enhance people’s self-efficacy [40],and to promote accurate illness perceptions [41]. It usesBehaviour Change Techniques (BCTs) [42] (see Additionalfile 1 for a list of BCTs utilised in SMS4BG) to address thebehaviours required for successful self-management and ismade up of modules allowing for tailoring to the individ-ual patient. The intervention content is designed to ad-dress the seven key self-management behaviours identifiedby the Association of American Diabetes Educations: (1)healthy eating, (2) being active, (3) monitoring, (4) taking

medication, (5) problem solving, (6) reducing risks, and(7) healthy coping [43]. In addition the intervention in-cludes versions for Māori and Pacific peoples incorporatingconcepts and elements specific to these cultures. Involve-ment of primary and secondary care teams throughout thedevelopment attempts to ensure integration into clinicalpathways. The pilot study found the programme accept-able, useful, and culturally and age-appropriate [37]. Feed-back from the SMS4BG pilot study allowed for furtherdevelopment and refinement of SMS4BG including in-creasing the duration of the programme based on patientpreference, the addition of new modules including a footcare module and a cardiovascular check reminder module,and increased tailoring to incorporate individual motiva-tions and names of support people. While the pilot studyyielded positive results, a larger-scale randomised con-trolled trial (RCT) of the effectiveness of SMS4BG is nowrequired including the effectiveness of SMS4BG in urban,and rural and remote areas. The findings from this RCTwill inform the decision on whether to scale up and imple-ment the programme across New Zealand.

AimThis study aims to determine the effectiveness of themHealth diabetes self-management support programme(SMS4BG) in adults with poorly controlled type 1 or type2 diabetes, in addition to their usual diabetes care. Specificobjectives include:

1. Enabling improved diabetes self-management asmeasured by improvements in glycosylated haemo-globin (HbA1c)

2. Assessing the effectiveness of SMS4BG in areas withhigh rural/remote populations

Methods/designThis protocol describes a 9-month, two-arm, parallel, RCTto evaluate the effectiveness of a text message-based dia-betes self-management support programme (SMS4BG), onglycaemic control as measured by HbA1c. This protocol isin accord with the Standard Protocol Items: Recommenda-tions for Interventional Trials (SPIRIT) 2013 statement[44], and the intervention is described according to theConsolidated Standards of Reporting Trials (CON-SORT)-EHEALTH checklist [45]. See Additional file 2for the completed SPIRIT checklist.

Study population and recruitmentEligible participants are adults (aged 16 years and over)with poorly controlled diabetes (defined as an HbA1c over65 mmol/mol in the preceding 9 months) who own a textmessage-capable mobile phone, are able to read English,provide informed consent, and are available for the studyduration. Exclusion criteria are not being available for the

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Confidential: For Review Onlyduration of the study, or being unable to use a mobilephone due to physical disabilities affecting eyesight ordexterity and not having a carer who wishes to use themobile tools on their behalf. Recruitment for the trialcommenced June 2015.Potential participants will be identified by clinicians

within primary and secondary care services across NewZealand health districts. Districts will be categorised aseither high urban population or high rural/remote popu-lation based on population destiny data. Recruitmentprocesses will build on those used successfully in thepilot study with clinicians forwarding the contact detailsof interested and eligible participants to the researchteam who will contact the patient by phone to discussthe study and gain informed consent. Informed consentwill be obtained from all participants before they are en-rolled in the study.

Outcome assessmentsAssessments will be conducted at baseline and 9 monthspost randomisation (see Fig. 1). Baseline assessments willinvolve collection of demographic information and self-reported outcome measures via phone interview, andcollection of clinical measures via patient records. Fol-lowing completion of baseline data collection the patient

will be randomised and, if allocated to the interventionarm, will be asked a small number of intervention-tailoring questions and will then be enrolled in the inter-vention. Intervention-tailoring questions include:

� Preferred first name� Preferred mobile number� Preferred message delivery time (early morning:

7–9 am, mid-morning: 9 am–12 pm, early after-noon: 12–3 pm, late afternoon: 3–5 pm, evening:5–8 pm, or day: 9 am–5 pm)

� Region (Auckland or non-Auckland)� Names and relationship of two support people

(partner, parent/caregiver, child, friend, other)� Motivations for diabetes management (your family,

your whānau, your partner, your husband, yourwife, your mum, your dad, your child, your children,your grandchild, your grandchildren, your friends,your career, your health in the future, sport, yourfitness)

� Module choices (See Table 1).

Follow-up assessments will involve completion of self-reported outcome measures via phone interview, andcollection of clinical measures via patient records.

Fig. 1 Study flow diagram


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Table 1 Description of SMS4BG modules

Module Description Participants Duration Example message

Core module Two messages per week providinggeneral motivation and support fordiabetes management. Available in3 version:MāoriPacificNon-Māori/non-Pacific

All 3 to 9 months SMS4BG: Kia ora. Control of your glucose levelsinvolves eating the right kai, exercise & takingyour medication. Your whānau, doctor & nursecan help you

SMS4BG: Talofa (name). by managing yourdiabetes well (including eating well andexercising) you can show your family thatdiabetes can be controlled

SMS4BG: There is no quick fix to diabetesbut with good management it will haveless impact on your life and leave you moretime to do the things you enjoy

Insulin module One educational text message perweek around insulin managementand hypos for patients receiving insulin

Available to participantswho are prescribed insulin

3 to 9 months SMS4BG: Keep unopened insulin in the fridge.Don’t use insulin that has changed colour,is lumpy, expired, cracked or leaking, or hasbeen frozen or overheated

Young adult module One message per week aroundmanaging diabetes in the contextor work/school and social situations

Available to participantsaged 16–24

3 to 9 months SMS4BG: Unsure whether to tell your friends/boyfriend/girlfriend about diabetes? This canbe tough but people who care about you willwant to know & support you

Smoking cessationmodule

One message per month encouragingparticipants to consider quittingsmoking and providing details ofservices for support

All participants whoregister as smokers

3 to 9 months SMS4BG: (hi) (name). Good management ofyour diabetes & your future health includesnot smoking, call Quitline on 0800 778 778for support

Lifestyle behaviourmodules

Up to 4 messages per week encouragingparticipants to set a lifestyle goal andsupporting them to work towards thisgoal. Participants can receive one ofthese modules for 3 months. The threelifestyle modules are:Healthy eatingExerciseStress and mood

Available to allparticipants

Each module3 months

SMS4BG: Healthy eating is an important partof your diabetes treatment and it will helpyou in controlling your blood glucose levels

SMS4BG: If you are too tired to exercise atthe end of the day, try waking up early &doing your exercise in the morning. It willenergise you for the day

SMS4BG: (hi) (name). Make sure you havefun activities scheduled regularly. Doingsomething enjoyable helps reduce stress& improves mood

Blood glucosemonitoring

Reminders to test blood glucose, sentat a frequency selected by the patient,for which they are encouraged torespond by reply text message withtheir blood sugar readings. In additioninformational messages aroundmanaging hypos.

Available to all participantsrequired to monitor theirblood glucose

3 to 9 months SMS4BG: (hi) (name). Just a reminder it istime to check your blood glucose. Replywith the result.

If valid response received to reminder,‘SMS4BG: Thank you for sending your result’

SMS4BG: Hypoglycaemias (hypos) are whenyour blood glucose drops too low (i.e. lessthan 4 mmol/L). If this happens takesomething with sugar immediately

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Table 1 Description of SMS4BG modules (Continued)

Foot care module Reminders and motivational messagessupporting engagement in foot care

Available to those who areclassified as high risk orhave active foot disease

3 to 9 months SMS4BG: Looking after your feet will help toprevent issues in the future. Check your feetdaily & contact your doctor, nurse or podiatristif there are changes

Cardiovascular checkreminder

Reminder to engage in a yearlycardiovascular assessment

Available to those whoqualify

3 months SMS4BG: (hi) (name). Next time you see yourdoctor ask about getting a cardiovascularcheck done. You should have one each year

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Confidential: For Review OnlyEthics approvalEthical approval for this trial was obtained from theHealth and Disability Ethics Committee (14/STH/162).

Sample sizeOne thousand participants (500 per arm) will be re-cruited for the trial, stratified by the health districts witheither high urban or high rural/remote populations.Recruiting 500 participants (250 per arm) in each of thehealth district populations will provide 90 % power atthe 5 % significance level to detect an overall clinicallymeaningful difference of 0.5 % (6 mmol/mol) change inHbA1c from baseline to 9 months between the twoarms in each of the populations, assuming a standarddeviation of 1.7 %. Targeted recruitment strategies willbe used to preferentially recruit Māori and Pacific partic-ipants where possible.

Randomisation and blindingEligible participants will be randomised to either interven-tion or control group in a 1:1 ratio. Randomisation will bestratified by health district category (high urban or highrural/remote), diabetes type (1 or 2), and ethnicity (Māoriand Pacific, or non-Māori and non-Pacific). The random-isation sequence will be generated by computer programmeusing variable block sizes of 2 or 4, and overseen by thestudy statistician (YJ). The treatment allocation will be con-cealed until the point of randomisation. Due to the natureof the intervention participants will be aware of their treat-ment allocation. Although it will not be possible for re-search staff conducting the phone interviews to be blindedto the treatment allocation, the primary outcome HbA1c isan objective measure and assessors of this outcome will beblinded to treatment allocation.

InterventionBoth intervention and control groups will continue withtheir usual diabetes care including all medical visits, tests,and diabetes support programmes. In addition the inter-vention group will receive the automated text message-based self-management support programme (SMS4BG) forup to 9 months. SMS4BG is tailored according to theneeds and goals of the patient, their care plan, and demo-graphic factors including ethnicity. As well as core motiv-ational and support messages (available in Māori, Pacificand non-Māori/non-Pacific versions), participants can optto receive additional modules such as a lifestyle modulearound healthy eating, physical activity or stress manage-ment. Where appropriate to their care, they can also re-ceive reminders to check blood glucose levels, messagesaround insulin, foot care, managing diabetes as a youngadult, and smoking cessation, and also messages encour-aging preventive behaviours (e.g. cardiovascular risk assess-ment). Participants who opt to reply to glucose monitoringreminders, by sending in their blood glucose levels by text

message, will be able to view their blood glucose levelsgraphically over time on a secure website. If at baselinethey are identified as not having access to the Internet theywill be mailed their graphs on a monthly basis. At registra-tion the intervention group will be able to select the timingof their messages and blood glucose monitoring reminders,and to identify their support people and motivations fordiabetes management for incorporation into the messages.The length of the programme will also be tailored to patientpreferences from 3 to 9 months, and at 3 and 6 monthsparticipants will receive a text message asking if they wouldlike to continue the programme for an additional 3 monthsand will be given the opportunity to re-select their modules.Participants can stop their messages at any time by textingthe word ‘STOP’, or put their messages on hold for 1 weekby sending the text word ‘HOLIDAY’. A summary of thestructure of SMS4BG can be seen in the Table 1. More de-tail on the intervention and its development is available inthe pilot study paper [37].The message delivery will be managed by a specifically

developed SMS4BG Content Management System withthe messages sent and received through a gateway com-pany to allow for participants to be registered with anyNew Zealand mobile network. Sending and receivingmessages will be free to all participants with costs cov-ered by the study. The system will maintain logs of alloutgoing and incoming messages, and incoming bloodglucose values will be automatically graphed by the sys-tem which individuals can view via a password-protectedwebsite.

Outcome measuresThe primary outcome measure is change in glycaemiccontrol from baseline to 9 months, measured as HbA1c(in mmol/mol or %) by registered laboratories. Second-ary outcome measures include:

� Glycaemic control measured by registered laboratorymeasurements of HbA1c (in mmol/mol or %) at3 months and at 6 months. Both 3-month and6-month HbA1c results will be obtained frompatient records at the 9-month follow-up

� Self-efficacy for diabetes management measured bythe Stanford Self-efficacy for Diabetes Managementscale (SEDM) [46] at baseline and at 9 months. TheSEDM is an 8-item measure which respondents useto indicate, on a Likert scale from 1 (not at allconfident) to 10 (totally confident), how confidentthey feel that they can carry out the listed tasksregularly at the present time. The score is calculatedusing the mean of the eight items with higher scoresindicating higher self-efficacy. The SEDM has beenfound to have good internal consistency andtest-retest validity [46]


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Confidential: For Review Only� Diabetes self-care behaviours measured by the

Summary of Diabetes Self-Care Activities [47](SDSCA) at baseline and at 9-month follow-up.The SDSCA is a brief self-reported questionnairewhich asks respondents 11 items relating to fivedifferent domains of diabetes self-management:diet, exercise, blood-glucose monitoring, foot care,and smoking. The SDSCA has been shown to havegood validity and reliability in research and practice[47], with higher scores on the scale indicating greaterengagement in self-care behaviours

� The presence of diabetes-related distress measuredby the 2-item Diabetes Distress Scale (DDS2) [48] atbaseline and at 9 months. This 2-item brief diabetesdistress screening instrument detects diabetes-specific distress. Respondents indicate, on a 6-pointLikert scale, to what degree each item has causedthem distress over the past month with higher scoreindicating higher distress. The DDS2 has beenshown to discriminate highly distressed patientsfrom patients with low diabetes distress [48], withan average item score of 3 or more used as the cutoff for high distress

� Cognitive and emotional representations of diabetesmeasured by the Brief Illness PerceptionQuestionnaire (BIPQ) [49] at baseline and at9 months. The BIPQ is a 9-item self-reportedmeasure which assesses consequences, timeline,personal control, treatment control, identity, concern,emotions, illness comprehensibility, and causes ofdiabetes. Each item (except causality) is rated using an11-point Likert scale with higher scores indicatinggreater agreement with the item. The causalrepresentation is assessed via an open-ended item.The BIPQ has been shown to have good reliabilityand validity [49], and has previously been used in aNew Zealand diabetes population to assess differencesin illness perceptions between Europeans, SouthAsians and Pacific Islanders [50]

� Health-related quality of life measured by theEuroQol 5 dimensions (EQ-5D) questionnaire [51]at baseline and at 9-month follow-up. The EQ-5Dprovides a descriptive profile of health status and asingle index value for health status. Five dimensionsof health are assessed in the descriptive system:mobility, self-care, usual activities, pain/discomfortand anxiety/depression. The respondent indicatesunder each dimension their health state by choosingthe severity level most appropriate to themselves. Alower number indicates a better health status andquality of life. The EQ-5D visual analogue scaleallows the respondent to mark, on a scale from 0(worst imaginable health state) to 100 (bestimaginable health state), their health state. There is

evidence to support the validity and reliability of theEQ-5D in people with diabetes [52]

� Perceived social support for diabetes managementmeasured using a 4-item measure developed for thisstudy at baseline and at 9-month follow-up. Themeasure is split into two sections. The first assessesgeneral support and asks how supported they feel inregards to their diabetes management on a 6-pointLikert scale, from 1 (not at all supported) to 6(extremely supported). The second section assessesappraisal, emotional and advice/information aspectsof support (one item each). Users indicate, on a6-point Likert scale ranging from 1 (strongly disagree)to 6 (strongly agree), to what degree they agree withthe statements

� Healthcare utilisation measured by number ofhospitalisations, and primary and secondary carevisits during the study period compared to the9 months prior to randomisation. Healthcareutilisation will be obtained from patient records at9-month follow-up

� Patient satisfaction and engagement with SMS4BG(for those in the intervention group). At 9 monthsparticipants will be asked, via semi-structuredinterview, about their satisfaction with theprogramme, including ease of use, issues arising,satisfaction with the text messages, salience andusefulness of the messages, and suggestions forimprovement. In addition the overall number of textmessages sent and received, response rates, andintervention duration will be measured by theSMS4BG content management system

� Cost-effectiveness of the intervention using costinformation obtained at 9 month follow-up,including the costs of the SMS4BG programme, thedirect medical costs (including cost of treatment,primary care, secondary care) and Quality-adjustedLife Years (QALYs)

Statistical analysisStatistical analyses will be performed using SAS version9.4 (SAS Institute Inc. Cary, NC, USA). All statistical testswill be two-sided at the 5 % significance level. All treat-ment evaluations will be performed on the principle ofintention-to-treat (ITT), using the observed data collectedfrom all randomised participants. Appropriate imputationmethods will be applied to the missing data on the pri-mary outcome. No imputation will be considered on othersecondary outcomes. A per-protocol analysis may be con-ducted on the subset of participants who are more com-pliant with the protocol with pre-defined criteria.Demographics and baseline characteristics will be sum-

marised using descriptive statistics. Continuous variableswill be summarised as numbers of observed values, mean,


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Confidential: For Review Onlystandard deviation, median, minimum and maximum.Categorical variables will be described as frequency andpercentage. Information collected on all primary and sec-ondary outcomes will be first summarised using descrip-tive statistics at baseline and at 9 months as appropriate.Results will be presented for each of the two treatmentgroups separately. Linear regression model will be used totest the effect of intervention on the primary outcome be-tween two groups, adjusting for baseline outcome value,health district category, type of diabetes, and ethnicity (i.e.the stratification factors). Model-adjusted means and theirdifference will be presented with 95 % confidence inter-vals. As pre-planned, the analysis will also be conductedfor each health district category separately as stratified,and the consistency of intervention effects will be testedin the main model using an interaction term betweentreatment group and health district category. A similarapproach will be applied to other continuous secondaryoutcomes. Generalised linear regression models will beapplied to categorical outcomes using an appropriate linkfunction (e.g. a logit link for binary distribution).Sensitivity analysis may be conducted on the primary

outcome if the proportion of missing data is greater than10 %. Both single and multiple imputations’ methodsmay be considered based on different assumptions onthe missing data, in order to assess the robustness oftreatment evaluation.If enough participants are recruited, subgroup analyses

by diabetes type and ethnic group will be conducted onthe primary outcome and key secondary outcomes, totest possible interactions with the intervention.

DiscussionThis paper describes the protocol for the SMS4BG trial toevaluate a text message-based diabetes self-managementsupport programme compared with usual care. This typeof intervention can provide tailored support betweenclinic visits for people with poorly controlled diabetes.This protocol builds on previous evidence for the role ofmHealth in people with diabetes. The SMS4BG study hasbeen designed to address limitations of previous diabetestext message studies. The intervention, developed by amultidisciplinary team, is comprehensive in design, indi-vidually tailored, and theoretically grounded, and thestudy design will allow for accurate assessment of the im-pact of this type of intention.Findings from the pilot study of SMS4BG show that

this type of intervention is acceptable and perceived asuseful by people with diabetes in New Zealand althoughthe effectiveness must be proven in a rigorously con-ducted trial. If found to be effective, SMS4BG has thepotential to be implemented into health services acrossNew Zealand and the potential to be adapted for otherpopulations.

Trial statusRecruiting: participants are currently being recruited andenrolled.

Additional files

Additional file 1: List of Behaviour Change Techniques (BCT) utilised inSMS4BG by grouping (BCT Taxonomy v1). (PDF 67 kb)

Additional file 2: SPIRIT 2013 Checklist. Completed SPIRIT checklist.(PDF 82 kb)

AbbreviationsBCT: Behaviour Change Technique; BIPQ: Brief Illness PerceptionQuestionnaire; DDS2: Diabetes Distress Scale – 2-item; DHB: District HealthBoard; ITT: intention-to-treat; QALY: Quality-adjusted Life Year;RCT: randomised controlled trial; SDSC: Summary of Diabetes Self-Care Activ-ities; SEDM: Self-efficacy in Diabetes Management scale; SMS: shortmessaging service; SMS4BG: self-management support for blood glucose.

Competing interestsThe authors declare that they have no competing interests.

Authors’ contributionsAll authors (RD, RW, YJ, RM, MS, KC, RC, CM, MK and RMu) contributed to thestudy concept, design, and procedures. RD drafted the manuscript. RD, YJ andRW created the statistical analysis plan and YJ carried out the randomisationsequence. RD, RW, RMu, and MS contributed to the intervention content.Access to data is limited to RD and YJ unless requested. All authors (RD, RW, YJ,RM, MS, KC, RC, CM, MK and RMu) read and approved the final manuscript.

Acknowledgements and fundingThis study was funded by the Health Research Council in partnership withWaitemata District Health Board and Auckland District Health Board (throughthe Research Partnerships for New Zealand Health Delivery initiative), andthe Ministry of Health. The funders were not involved in any way in thepreparation of this paper.We would like to thank the National Institute for Health Innovation’s IT team fortheir work on the text message delivery system, in particular Johan Strydom.We would also like to thank all those involved in the study design and set up,and content development, in particular Coral Skipper, Louise Elia, Erana Poulsen,Aumea Herman, Joanne Naylor, Michelle Garrett, Melanie Potter, HannahBartley, Michelle Jenkins, and Richard Edlin.

Author details1National Institute for Health Innovation, University of Auckland, Private Bag92019, Auckland 1142, New Zealand. 2Waitemata District Health Board,Auckland, New Zealand. 3School of Counselling, Human Services and SocialWork, Faculty of Education, University of Auckland, Auckland, New Zealand.4Auckland District Health Board, Auckland, New Zealand. 5School ofMedicine, Faculty of Medical and Health Sciences, University of Auckland,Auckland, New Zealand.

Received: 18 November 2015 Accepted: 22 March 2016

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SMS4BG RCT 2015 Protocol – Version 5

Confidential Not for Public Circulation or Reproduction

SMS4BG RCT Date: 01/04/2016 © The University of Auckland, 2015 1

Protocol

SMS4BG: A randomised controlled trial of a text message based diabetes

self-management support intervention

U1111-1162-7072 Trial Registration Number ANZCTR: ACTRN12614001232628

Principal Investigator

Dr Robyn Whittaker National Institute for Health Innovation, University of Auckland

09 373 7599 ext. 84766

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SMS4BG Project Co-ordinating Centre

Postal address National Institute for Health Innovation School of Population Health The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142 New Zealand Tel: 64 9 373 7999 Fax: 64 9 373 1710 Email: [email protected]

Street address National Institute for Health Innovation Level 4, School of Population Health Tamaki Campus The University of Auckland 261 Morrin Road Glen Innes Auckland 1072 New Zealand

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Investigators Dr Robyn Whittaker Principal Investigator

National Institute for Health Innovation University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 9 373 7599 ext. 84766 Fax: 64 9 373 1710 Emergency no: 021968029 Email: [email protected]

Mr Tim Wood Co-Investigator

Waitemata District Health Board Funding & Planning North Shore Hospital Private Bag 93 503 Takapuna North Shore City 0740 Tel: 64 9 486 8920 ext 3601 Emergency no: not available Email: [email protected]

Associate Professor Ralph Maddison Co-Investigator

National Institute for Health Innovation University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 9 923 4767 Fax: 64 9 373 1710 Emergency no: not available Email: [email protected]

Ms Rosie Dobson Co-Investigator

National Institute for Health Innovation University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 21 767 437 Fax: 64 9 373 1710 Emergency no: 021 767437 Email: [email protected]

Dr Matt Shepherd Co-investigator

School of Counselling, Human Services and Social Work University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 9 373 7599 ext. 46368 Fax: 64 9 623 8903 Emergency no: Not Available Email: [email protected]

Dr Rick Cutfield Co-investigator

Department of Endocrinology North Shore Hospital Private Bag 93 503 Takapuna North Shore City 0740

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mailto:m.shepherd@auckland





Tel: 64 9 486 1491 Fax: 64 9 441 8906 Emergency no: not available Email: [email protected]

Dr Catherine McNamara Co-investigator

Department of Endocrinology North Shore Hospital Private Bag 93 503 Takapuna North Shore City 0740 Tel: 64 9 486 8900 Fax: 64 9 441 8906 Emergency no: not available Email: [email protected]

Dr Rinki Murphy Co-investigator

School of Medicine, FMHS University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 9 923 6313 Fax: Emergency no: not available Email: [email protected]

Dr Manish Khanolkar Co-investigator

Auckland Diabetes Centre Greenlane Clinical Centre Private Bag 92189 Auckland 1142, New Zealand Tel: 64 21 815901 Fax: Emergency no: not available Email: [email protected]

Dr Yannan Jiang Co-investigator

National Institute for Health Innovation University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 9 923 4725 Fax: 64 9 373 1710 Emergency no: not available Email: [email protected]

Project Management Committee Members Dr Robyn Whittaker Principal Investigator

National Institute for Health Innovation University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 9 373 7599 ext. 84766 Fax: 64 9 373 1710 Emergency no: 021968029 Email: [email protected]

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Rosie Dobson PhD Candidate

National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand Tel: 64 21 767437 Fax: 64 9 373 1710 Emergency no: not available Email: [email protected]

Karen Carter Lead Project Manager

National Institute for Health Innovation University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 9 373 7599 ext. 87863 Fax: 64 9 373 1710 Emergency no: not available Email: [email protected]

Johan Strydom Senior Developer

National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand Tel: 64 9 373 7599 ext. 84715 Fax: 64 9 373 1710 Emergency no: Not available Email: [email protected]

Sheila Fisher Business Manager

National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand Tel: 64 9 373 7599 ext. 84717 Fax: 64 9 373 1710 Emergency no: 027 674 3452 Email: [email protected]

Project Co-ordinator Rosie Dobson PhD Candidate

National Institute for Health Innovation University of Auckland Private Bag 92019 Auckland 1142, New Zealand Tel: 64 21 767 437 Fax: 64 9 373 1710 Emergency no: 021767437 Email: [email protected]

Study Centres National Institute for Health Innovation Waitemata District Health Board Auckland District Health Board

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Co-ordinating Centre (NIHI) Staff

Name Position Telephone 09 373 7599 ext Email

Dr Robyn Whittaker

Principal Investigator, Programme Leader Health Informatics and Technology

84766 [email protected]

Rosie Dobson Project Co-ordinator/ PhD student

N/A [email protected]

Karen Carter Lead Project Manager 87863 [email protected]

Johan Strydom Senior Developer 84715 [email protected]

Dr Yannan Jiang Senior Biostatistician N/A [email protected]

Sheila Fisher Contracts Manager 84717 [email protected]

Study Centres Staff

Name Position Telephone Email

Dr Rick Cutfield Co-investigator/ Diabetes Specialist WDHB

64 9 486 1491 [email protected]

Dr Catherine McNamara Co-investigator/ Diabetes Specialist WDHB


Dr Rinki Murphy Co-investigator/ Diabetes Specialist ADHB


Dr Manish Khanolkar Co-investigator/ Diabetes Specialist ADHB

64 21 815901 [email protected]

Vicki Scott Senior Programme Manager ADHB & WDHB

64 9 486 8920 ext. 3142

[email protected]

Jagpal Benipal Senior Programme Manager ADHB & WDHB

64 9 443-9078 ext 7078

[email protected]

Project Sponsors The Health Research Council in partnership with WDHB and ADHB (through the Research Partnerships for New Zealand Health Delivery initiative), and the Ministry of Health are the principal sponsors of this trial. The design, conduct, analyses and interpretation of trial results will be made independent of the trial sponsor.

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Signature Page Author(s): Authors Name

Signature: Date:

Dr Robyn Whittaker

Ms Rosie Dobson

NIHI Signatory: Director

Signature: Date:

Associate Professor Chris Bullen

Revision Chronology: Date

Type e.g. Original

SMS4BG Protocol Version 1 14/10/2014 Original SMS4BG Protocol Version 2 18/11/2014 Amendment SMS4BG Protocol Version 3 13/01/2015 Amendment SMS4BG Protocol Version 4 16/09/2015 Amendment SMS4BG Protocol Version 5 01/04/2016 Amendment

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Table of contents

SMS4BG PROJECT CO-ORDINATING CENTRE ................................................................................. 2 INVESTIGATORS ................................................................................................................................... 3

PROJECT MANAGEMENT COMMITTEE MEMBERS .......................................................................... 4

PROJECT CO-ORDINATOR .................................................................................................................. 5

STUDY CENTRES .................................................................................................................................. 5

CO-ORDINATING CENTRE (NIHI) STAFF ............................................................................................ 6

STUDY CENTRES STAFF ...................................................................................................................... 6 PROJECT SPONSORS .......................................................................................................................... 6

SIGNATURE PAGE ................................................................................................................................ 7

TABLE OF CONTENTS .......................................................................................................................... 8

1. OVERVIEW ................................................................................................................................... 10

2. STUDY FLOW DIAGRAMS ......................................................................................................... 12 3. BACKGROUND ............................................................................................................................ 14

4. RATIONALE FOR THE PRESENT STUDY ................................................................................. 16

5. STUDY OBJECTIVES .................................................................................................................. 16

6. STUDY DESIGN ........................................................................................................................... 16

6.1 INCLUSION CRITERIA ............................................................................................................... 16 6.2 EXCLUSION CRITERIA .............................................................................................................. 16 6.3 RECRUITMENT AND BASELINE DATA COLLECTION..................................................................... 16 6.4 RANDOMISATION .................................................................................................................... 17 6.5 BLINDING ............................................................................................................................... 17 6.6 STUDY INTERVENTION ............................................................................................................. 17 6.7 WITHDRAWAL CRITERIA ........................................................................................................... 19 6.8 BASELINE ASSESSMENTS ........................................................................................................ 19 6.9 FOLLOW UP MEASURES ........................................................................................................... 20 6.10 SCHEDULE OF INTERVENTION AND FOLLOW-UP ......................................................................... 21 6.11 DETAIL OF CONTACT WITH PARTICIPANTS ................................................................................. 22

6.11.1 Eligibility and consent .................................................................................................. 22 6.11.2 Registration ................................................................................................................. 22 6.11.3 Intervention group: Intervention 3 month extension .................................................... 22 6.11.4 Follow up ..................................................................................................................... 22

6.12 DETAIL OF CLINICAL MEASURES ............................................................................................... 22 6.12.1 Registration ................................................................................................................. 22 6.12.2 Follow up ..................................................................................................................... 23

6.13 SUB-STUDY: WAITLIST CONTROL (SMS4BG-WCS) ................................................................. 23 6.13.1 Inclusion criteria: .......................................................................................................... 23 6.13.2 Procedures .................................................................................................................. 23 6.13.3 Study outcomes ........................................................................................................... 24 6.13.4 Analysis ....................................................................................................................... 24

6.14 LONG TERM FOLLOW UP .......................................................................................................... 24 7. STATISTICAL CONSIDERATIONS ............................................................................................. 25

7.1 SAMPLE SIZE .......................................................................................................................... 25 7.2 STUDY OUTCOMES .................................................................................................................. 25 7.3 STATISTICAL ANALYSIS ............................................................................................................ 25

7.3.1 Baseline characteristics ................................................................................................... 25 7.3.2 Intervention effects .......................................................................................................... 26

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7.3.3 Procedures to account for missing data .......................................................................... 26 7.3.4 Interim analyses ............................................................................................................... 26

7.4 DATA SAFETY AND MONITORING............................................................................................... 26 7.5 DATA MANAGEMENT ................................................................................................................ 26

8. ETHICAL APPROVAL AND CONSENT ...................................................................................... 27

8.1 NATIONAL ETHICS APPROVAL ................................................................................................... 27 8.2 INFORMED CONSENT ............................................................................................................... 27

9. SAFETY AND ADVERSE EVENTS ............................................................................................. 27

9.1 UNBLINDING ........................................................................................................................... 27 9.2 DATA SAFETY AND MONITORING............................................................................................... 27

10. CLINICAL SUPPLIES .............................................................................................................. 27

11. RELEVANCE TO HEALTH ...................................................................................................... 27

12. DISSEMINATION OF RESULTS ............................................................................................. 28

12.1 STUDY PARTICIPANTS ............................................................................................................. 28 12.2 THE GENERAL PUBLIC ............................................................................................................. 28 12.3 ACADEMIC/PROFESSIONAL COLLEAGUES .................................................................................. 28 12.4 HEALTH SERVICE FUNDERS AND PROVIDERS ............................................................................ 28 12.5 IWI/ MĀORI ............................................................................................................................. 28 12.6 PACIFIC ISLAND COMMUNITIES ................................................................................................. 28

13. ADMINISTRATIVE SECTION .................................................................................................. 29

13.1 ADHERENCE TO THE PROTOCOL .............................................................................................. 29 13.2 PROTOCOL REVISION PROCEDURES ......................................................................................... 29 13.3 FORM PROCEDURES ............................................................................................................... 29 13.4 MONITORING/ SOURCE DOCUMENT VERIFICATION ..................................................................... 29 13.5 DATA CONFIDENTIALITY AND SECURITY .................................................................................... 30 13.6 REPORTING SCHEDULE ........................................................................................................... 30 13.7 RECORD RETENTION POLICY ................................................................................................... 30 13.8 INSURANCE ............................................................................................................................ 30 13.9 OWNERSHIP OF DATA AND PUBLICATION POLICY ....................................................................... 30

14. STUDY ACKNOWLEDGEMENT ............................................................................................. 31

15. REFERENCES ......................................................................................................................... 32

16. APPENDIX 1 – TERMS OF REFERENCE .............................................................................. 34

16.1 PROJECT MANAGEMENT COMMITTEE....................................................................................... 34 16.2 TRIAL STEERING COMMITTEE .................................................................................................. 34

17. APPENDIX 2 – INFORMED CONSENT PROCEDURES AND FORMS ................................. 35

17.1 INFORMED CONSENT ............................................................................................................... 35 18. APPENDIX 3 – PROPOSED TIMELINE .................................................................................. 36

19. APPENDIX 4 – DECLARATION OF HELSINKI ...................................................................... 38 20. APPENDIX 5 – SUMMARY OF PROTOCOL AMENDMENTS ............................................... 43

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1. Overview Title of study SMS4BG: A randomised controlled trial of a text message based diabetes self-management support intervention Investigators and study centres This study has been designed by independent investigators at the National Institute for Health Innovation (NIHI), School of Population Health (SOPH), University of Auckland (UoA) in consultation with clinicians, consumers and Māori. The overall design and conduct of this trial is the responsibility of the principal investigator and members of the Project Management Committee. Publication of data from this trial will be the responsibility of members of the Project Management Committee. The study will be co-ordinated from the NIHI, with participants recruited from designated recruitment centres. Study period November 2014 – December 2016 Objectives The primary objective is to determine the effectiveness of the mHealth diabetes self-management support programme (SMS4BG: Self-management support for blood glucose) in adults with Type 1 or Type 2 diabetes, in addition to their usual diabetes care. In addition this study will assess the effectiveness of SMS4BG in regions with high rural and remote populations. The trial results will inform the District Health Boards’ (DHB) and Ministry of Health’s (MOH) decision on whether to scale up and implement the programme across the districts/New Zealand. Study duration 24 months. Study design and methodology A parallel, two-arm, randomised controlled trial to test the effectiveness of the SMS4BG text messaging self-management support programme in addition to standard care. Recruitment will take place via primary care (Primary Care Organisations (PHOs)) or secondary care services across Auckland DHB/PHO regions (Auckland District Health Board (ADHB), Waitemata District Health Board (WDHB) and Counties Manukau District Health Board (CMDHB)) and non-Auckland DHB/PHO regions with high rural and remote populations. Potentially eligible people will be invited to participate via 1) their DHB diabetes service or Primary Healthcare Organisation (PHO), or 2) flyers distributed through diabetes networks and if interested a trained research assistant (RA) will obtain consent and collect baseline data by phone. Randomisation by a central computerised system will allocate participants either to receive the SMS4BG programme for up to 9 months in conjunction with their usual diabetes care, or to continue to receive usual diabetes care alone. Those randomised to receive the intervention will receive a tailored package of text messages for 3 to 9 months. All participants will be followed up at 9 months by phone. A lab test form will be sent for HbA1c to be measured and results obtained through medical records.

Study population People with Type 1 or Type 2 diabetes, who have had a HbA1c >65mmol/mol within the past 9 months, have a mobile phone, and are able to provide informed consent. Sample size

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Recruiting 500 participants (250 per arm) in two Auckland DHB regions will provide 90% power at 5% significance level to detect an overall clinically meaningful difference of 0.5% (6 mmol/mol) in change in HbA1c from baseline to 9 months between the two arms, assuming a standard deviation of 1.7%. Same recruitment target (500 participants with 250 per arm) will be set for all non-Auckland DHB/PHO regions, which will provide the same statistical power to evaluate the effect of intervention in rural and remote population. The total sample size for the trial will therefore be 1000 participants. As many Māori and Pacific participants as possible will be recruited to allow for subgroup analyses by ethnicity grouping (Maori/Pacific, and non-Maori/Pacific).

Main criteria for inclusion

• Aged 16 years or older

• Have type 1 or type 2 diabetes

• Have an HbA1c≥65mmol/mol within the preceding 9 months (i.e. latest HbA1c test result)

• Have a mobile phone that can be used for this programme

• Provides informed consent

• Able to read English Exclusion criteria

• Not available for the duration of the programme

• Unable to use a mobile phone due to physical disabilities affecting eyesight or dexterity and do not have a carer who wishes to use the mobile tools on their behalf.

Study outcomes The primary outcome will be the change in HbA1c level from baseline to 9 months. Baseline HbA1c will be the result from the latest test at enrolment within the preceding three months. Secondary outcomes include health behaviours, self-efficacy, diabetes distress, health related quality of life, perceived social support and illness perceptions. For those that are randomised to the intervention group, engagement/ interaction with the programme and satisfaction and feedback will be assessed. Health service utilisation and cost data will also be collected. Statistical analysis Treatment evaluations will be performed on the principle of intention to treat. The change in HbA1c from baseline to 9 months will be analysed using the analysis of covariance regression model to test the treatment difference between two groups, adjusting for baseline outcome value, diabetes type, and ethnicity. The effect of intervention will be evaluated separately for Auckland DHBs and non-Auckland DHBs. Same regression analyses will be conducted on other continuous secondary outcomes. Generalized linear models will be applied to categorical outcomes as appropriate. Thematic analysis will be used to explore the patient satisfaction and feedback. Funding The Health Research Council in partnership with WDHB and ADHB (through the Research Partnerships for New Zealand Health Delivery initiative), and the Ministry of Health are the principal sponsors of this trial

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2. Study Flow Diagrams Figure 1: Flow diagram of the study protocol

PHO’s/DHB’s identify potential participants

and invite them to take part in the study

RA’s contact interested potential

participant(s) by phone and gain verbal

informed consent

Baseline measures completed: Demographics

Behavioural and psychological measures Clinical measures

BASELINE

SCREENING

RANDOMISATION

Control group (n=500)

Standard care

Intervention group (n=500)

Standard care & SMS4BG

FOLLOW UP

9-Month follow up measures completed: Behavioural and psychological measures

Clinical measures Usability, satisfaction and engagement (Intervention group only)

Lab test form sent for HbA1c by DHB and results obtained from records

Potential participants contact research team

Eligibility checked

RA’s contact participant by phone

and gain verbal informed consent

Clinicians identify potential participants in waiting rooms/

wards/clinics

RA’s contact interested participant(s) by phone and gain

verbal informed consent

RA gives patient a flyer/ overview & gets permission to

phone them to discuss

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Figure 2: Flow diagram of the SMS4BG intervention

MODULE OPTIONS

Core Māori Pacific Non-Māori/Pacific

Insulin If on insulin

Young adult If aged 16 to 24 years

Smoking If smoker

Foot care If high risk

Cardiac check If meet criteria

Monitoring 1/wk 3/wk 1/day 2/day 3/day 4/day No

Lifestyle Healthy eating Exercise Stress/mood No

Intervention group (n=500) Standard care & SMS4BG

Participant selects modules & completes tailoring questions

Messages begin

3 months

Baseline

SMS sent offering further 3 months “NO”

Participant selects modules

MODULE OPTIONS

Core

Previous selections continue

Insulin

Young adult

Smoking

Foot care


Lifestyle1 Healthy eating Exercise Stress/mood No

SMS sent offering further 3 months

6 months “YES”

Participant selects modules

Intervention ends: 9 month follow up 9 months

“YES”

“NO”

MODULE OPTIONS

Core

Previous selections continue

Insulin

Young adult

Smoking

Foot care


Lifestyle1 Healthy eating Exercise Stress/mood No

1Each lifestyle can only be chosen once

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3. Background Addressing increasing diabetes prevalence, its associated morbidity and health inequalities, is a current priority for New Zealand.1-3 Diabetes self-management including glucose monitoring, engaging in health behaviours, insulin administration, and healthcare provider contact are associated with improved glycaemic control and even small improvements in glycaemic control are associated with reduction in costly and debilitating long-term complications.4-7 Mobile phone ownership and use in New Zealand is increasing and is consistent across Māori and non-Māori people.8 SMS (text message) volumes have continued to rise over recent years with nearly 14 billion SMS messages sent in New Zealand in the year ending June 20129 corresponding to NZ having the highest use of SMS by head of population compared to other OECD countries. In light of the increasing prevalence of diabetes in New Zealand, as well as increasing mobile phone ownership (across cultural and socio-economic groups), we hypothesize that technology-based tools are important options for self-management support in this population. Mobile phone based health interventions provide an ideal way of providing patient-centred care at the frequency and intensity that patients would ideally benefit from. This proposal outlines a study to assess the effectiveness of a novel intervention for supporting people with diabetes to achieve better glycaemic control, improve self-management behaviours and improve communication with their multidisciplinary (community, primary and secondary) healthcare team. Mobile technology has been used effectively in supporting healthy behaviour change and disease management.10-12 There is a growing body of evidence supporting the use of mobile phones in the management of diabetes,13-16 with a 2011 meta-analysis of 22 studies concluding that there was evidence that mobile phone interventions led to statistically significant improvements in glycaemic control (HbA1c).13 However, many of the studies to date have lacked sufficient sample sizes or were of insufficient duration to produce an effect. Another gap in diabetes mHealth interventions to date includes a lack of theoretical grounding17 or important behaviour change constructs including self-efficacy and illness perceptions and beliefs.18 Most of the interventions studied were not comprehensive in that they focused solely on monitoring reminders or entering glucose measurements, and did not involve providers or current clinical practice.13,14 The National Institute for Health Innovation (NIHI) at the University of Auckland undertook an 18 month scoping and feasibility exercise with key stakeholders, patients and primary and secondary health care providers from the WDHB, to identify patient and clinical needs in diabetes care, assess and understand current gaps in addressing those needs, and identify technology-based tools to support better integrated care and self-management. Key areas of need identified through focused discussions with hospital-based diabetes services and multidisciplinary primary care teams included tools to support and encourage self-management in patients. Particular target groups identified included those struggling with motivation to control their condition well, those wanting more dietary education/information, those commencing insulin therapy, and those with current limited access to services and technology. Clinicians also expressed interest in integrating technology based tools into their current IT systems. Following clinician discussions, the team interviewed people with diabetes to gauge their perspectives on potential areas for improvement. Early input confirmed that not all patients have good access to or interest in high-end technology (e.g. smartphones, broadband), and that needs and interests in self-management support vary widely across the diverse patient cohort. As a result of the input from patients and clinicians a mobile phone based text messaging programme to enhance self-management support for people with diabetes (‘SMS4BG’: Self-Management Support for Blood Glucose) was developed and piloted.

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Development of the SMS4BG intervention followed a process used in previous NIHI mHealth developments, including a video messaging smoking cessation intervention, multimedia messaging to prevent the onset of depression in adolescents, an exercise prescription and support programme for people with cardiovascular disease, and a text messaging weight management intervention. This process as described in a peer-reviewed published article19

provides a framework to guide the development and testing of mHealth interventions with a focus on implementation, use of behavioural change theory and involvement of the target population. The framework proposes a number of steps for the development and evaluation of the intervention, including conceptualisation, formative research and pretesting, pragmatic randomised controlled trial (RCT) and qualitative follow-up. Consistent across all stages is the engagement of key stakeholders, including clinicians and patients. The conceptualisation stage involved interviews and surveys with WDHB diabetes service clients. The results were used to inform the design of the self-management mHealth support tool(s) to meet the needs of a range of people with diabetes and to optimise use and value. This stage also included a review of the evidence for mobile health to support self-management of diabetes, and a review of existing mHealth tools. SMS4BG was developed by a multidisciplinary team including public health and mHealth experts, psychologists, diabetes nurse specialists, a Māori advisory group, with review and input from diabetes specialists and primary care teams. The intervention is grounded in behaviour change theory to enhance people’s self-efficacy,20 and promote accurate illness perceptions.21 It uses behaviour change techniques (i.e. goal setting, self-monitoring, motivation, and self-review) to address the behaviours required for successful self-management and is made up of modules allowing for tailoring to the individual patient. Involvement of primary and secondary care teams attempts to ensure integration into clinical pathways. A pilot study of 42 participants with type 1 or type 2 diabetes (2 withdrew; 39 completed follow up interviews) recruited from primary and secondary care in WDHB was carried out in 2013.22 Of those that took part in the pilot study 36% were Māori, 48% were male and the mean age was 46 years (range 17 to 69 years). During the three month programme participants received up to 437 messages, depending on their choice of modules (see programme structure p12), with the mean messages received per person being 109. Results from the follow up interviews showed that all participants found the programme useful, reported it to be culturally and age appropriate and would recommend it to others with diabetes.22 In addition, over 80% of participants interviewed reported a perceived positive impact of the programme on their overall blood glucose control. Other reported perceived positive impacts of the programme included improved diet (59% of participants), physical activity (49%), mood (67%), knowledge of diabetes (49%), and perceptions of diabetes (41%). Three of the ten participants who registered as smokers reported that they had quit smoking and credited the programme in supporting them to do this. Of those participants who opted to receive blood glucose monitoring reminders (n=34), 94% reported that the reminders were useful, 87% reported that the reminders increased how often they tested their blood glucose, and 76% replied to the reminders by texting in their blood glucose results. Clinicians stated that they would like it to be made available to other patients and reported no problems with the programme or the referral/sign up process. Of the 26 participants with baseline and follow-up test results available, 21 participants improved their HbA1c level (a measure of long-term diabetes control) and overall there was a statistically significant mean reduction in HbA1c of 14mmol/mol. This positive result is higher than the pooled difference in HbA1c of 6mmol/mol as presented in the meta-analysis by Liang et al.13

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4. Rationale for the Present Study Better diabetes management is one of the Ministry of Health’s national health targets (specifically, “increased percent of people with diabetes will have satisfactory or better diabetes management and increased percent of people with diabetes will attend free annual checks”). This research aims to assist people with diabetes to better manage their condition and therefore reduce the likelihood of long-term costly and debilitating complications. Feedback from the SMS4BG pilot study has allowed for further development and refinement of SMS4BG to be undertaken. While the pilot study yielded positive results a larger scale randomised controlled trial (RCT) of the effectiveness of SMS4BG is now required including the effectiveness of SMS4BG in DHB districts with high rural and remote populations. The findings from this RCT will inform the decision on whether to scale up and implement the programme across New Zealand.

5. Study Objectives This study aims to determine the effectiveness of the mHealth diabetes self-management support programme (SMS4BG) in adults with Type 1 or Type 2 diabetes, in addition to their usual diabetes care. Specific objective include: 1. Enable improved diabetes self-management as measured by improvements in HbA1c 2. Assess effectiveness of SMS4BG in DHB/PHO’s with high rural/remote populations 3. Provide information for the DHB Funding/Primary care team and the Ministry of Health to

inform a potential roll-out of the programme, including the optimal components of the programme and methods for scaling up and integrating into existing clinical pathways, health IT systems, and an improved model for integrated care for people with diabetes.

6. Study Design A two-arm parallel randomised controlled trial.

6.1 Inclusion criteria

• Aged 16 years or older

• Have type 1 or type 2 diabetes

• Have an HbA1c ≥ 65mmol/ml as assessed within the prior 9 months (i.e. currently poorly controlled - the most recent HbA1c result will be accessed, with the patients consent, from their medical records)

• Have a mobile phone that can be used for this programme

• Provides informed consent

• Able to read English

6.2 Exclusion criteria

• Not available for the duration of the programme

• Unable to use a mobile phone due to physical disabilities affecting eyesight or dexterity and do not have a carer who wishes to use the mobile tools on their behalf.

6.3 Recruitment and Baseline Data Collection The study will take place within three Auckland DHB regions (WDHB, CMDHB, and ADHB) and non-Auckland DHB/PHO regions with high rural and remote populations. Recruitment processes will build on those used successfully in the pilot study. Investigators will work with

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DHB diabetes services and PHO’s to identify and inform potentially eligible patients and establish appropriate processes for contacting them. This will happen through 3 different methods: 1) Potentially eligible people will be invited to participate by their clinician and details sent to NIHI, 2) Potentially eligible people in wards or waiting rooms identified by their clinician will be given a flyer/information about the study and invited to take part, or 3) Potential participants will be able to self-refer to the study. The RAs at NIHI will contact interested and eligible participants by phone to inform them about the study and gain informed consent. Those who provide verbal informed consent will complete baseline data collection by phone with the RA. The RA will complete and send a hard copy of the consent form to each participant. The consent form will note that consent was given verbally by the participant on the appropriate date. NIHI will retain a copy of the consent form.

6.4 Randomisation Following baseline data collection, eligible participants will be randomised to either intervention or control group in a 1:1 ratio and stratified by DHB region (Auckland or non-Auckland), diabetes type (1 or 2), and ethnicity (Māori & Pacific, or non-Māori & non-Pacific). The randomisation sequence will be generated by computer program and allocation concealed until the point of randomisation.

6.5 Blinding Due to the nature of the intervention, participants will be aware of their treatment allocation. Although it will not be possible for research staff to be blinded to the treatment allocation the key health outcome HbA1c is not subject to bias.

6.6 Study intervention Both intervention and control groups will continue with their usual diabetes care including all medical visits, tests and diabetes support programmes. In addition the intervention group will receive the mobile-based self-management support programme for up to 9 months. SMS4BG is tailored according to the needs and goals of the patient, their care plan, and demographic factors including ethnicity. As well as core motivational and support messages (available in Māori, Pacific and non-Māori/Pacific versions), participants can receive additional modules such as a lifestyle module around healthy eating, physical activity or stress management. Where appropriate to their care, they can also receive reminders to check blood glucose levels, messages around insulin, foot care, managing diabetes as young adult, smoking cessation, and messages encouraging preventive behaviours (e.g. cardiovascular risk assessment). Participants that opt to reply to monitoring reminders, by sending in their blood glucose levels by text message (not compulsory), will be able to view their blood glucose levels graphically over time on the study website. If at baseline they are identified as not having access to the internet they will be posted their graphs on a monthly basis. The length of the programme will also be tailored to patient preferences from three to nine months. At the end of each three month period participants will be offered the option of extending the intervention by another three months, up to a possible 9 months. This allows participants the option of working towards different goals each three month period. At registration the intervention group will be able to select the timing of their core messages and blood glucose monitoring reminder messages (morning, afternoon, or evening) to ensure the timing is appropriate to their needs. A summary of the structure of SMS4BG can be seen in the Table 1 below. Table 1: Description of SMS4BG modules

Module Description Participants Duration Example message

Core module Two messages per week providing general motivation and support for diabetes

All

3 to 9 months


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management. Available in 3 version:

- Māori - Pacific

- Non-Māori/Non-Pacific

SMS4BG: Talofa [name]. by managing your diabetes well (including eating well and exercising) you can show your family that diabetes can be controlled

SMS4BG: There is no quick fix to diabetes but with good management it will have less impact on your life and leave you more time to do the things you enjoy

Insulin module One educational text message per week around insulin management and hypos for patients receiving insulin

Available to participants who are prescribed insulin

3 to 9 months

SMS4BG: Keep unopened insulin in the fridge. Don’t use insulin that has changed colour, is lumpy, expired, cracked or leaking, or has been frozen or too hot

Young adult module

One message per week around managing diabetes in the context or work/school and social situations

Available to participants aged 16 - 24

3 to 9 months


Smoking cessation module

One message per month encouraging participants to consider quitting smoking and providing details of services for support

All participants who register as smokers

3 to 9 months


Lifestyle behaviour modules

Up to 4 messages per week encouraging participants to set a lifestyle goal and supporting them to work towards this goal Participants can receive one of these modules for three months. The three lifestyle modules are:

- Healthy eating

- Exercise

- Stress and mood.

Available to all participants.

Each module 3 months


SMS4BG: If you are too tired to exercise at the end of the day, try waking up early & doing your exercise in the morning. It will energize you for the day


Blood glucose monitoring

Reminders to test blood glucose, sent at a frequency selected by the patient, for which they are encouraged to respond by reply text message with their blood sugar readings. In addition informational messages around managing hypos.

Available to all participants required to monitor their blood glucose

3 to 9 months

SMS4BG: [hi] [name]. Just a reminder it is time to check your blood glucose. Reply with the result

If valid response received to reminder, “SMS4BG: Thank you for sending your result”

SMS4BG: Hypoglycaemia (hypos) are when your blood glucose drops too low (i.e. less than 4mmol/L). If this happens take something with sugar immediately

Foot care module

Reminders and motivational messages supporting engagement in foot care

Available to those that are classified as high risk or have active foot disease

3 to 9 months

SMS4BG: Looking after your feet will help to prevent issues in the future. Check your feet daily & contact your doctor, nurse or podiatrist if there are changes

Cardiovascular check reminder

Reminder to engage in a yearly cardiovascular assessment

Available to those that qualify

3 months SMS4BG: [hi] [name]. Next time you see your doctor ask about getting a cardiovascular check done. You should have one each year.

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6.7 Withdrawal criteria Participants will be informed that they may withdraw from the study or from the intervention at any time. Their withdrawal will not affect their participation in usual care. The Investigator may withdraw the participant from the study if they feel it is in their best interest, or the study is terminated. Clinicians will be able to stop the programme on behalf of participants if deemed clinically appropriate.

6.8 Baseline assessments Potentially eligible participants identified by collaborating clinicians/sites will be contacted by to provided information about the study and invite them to take part. If the potential participant is interested permission will be sought to pass their details on to the RA at NIHI who will contact them to discuss the Patient Information Sheet (PIS) and consent Form. Alternatively participants who have heard about the study through flyers, clinicians of diabetes networks will can self-refer to the study. Following explanation of the study the participant’s eligibility will be checked before proceeding with the PIS and consent form. Hard copies of the PIS and consent form will be posted to all interested participants. Participants will be encouraged to discuss their participation with whanau, family and friends. Once verbal informed consent has been given the RA will confirm eligibility, and complete baseline measures. Baseline HbA1c will be the result from the latest test at enrolment within the preceding nine months. HbA1c results will be obtained from medical records. Baseline measures are described below:

- Form Z:

o Contact details: Title, name, initials, mobile phone number, alternative contact number, postal address

- Form A:

o Eligibility criteria: Inclusion/exclusion criteria, and registration number (i.e. SMS001)

o Demographic information: Gender, date of birth, ethnicity, employment status, postcode, DHB region (Auckland or non-Auckland).

o Clinical information (obtained from referrer and medical records): NHI, HbA1c result and date, diabetes type, Diabetes Foot Screening risk category, Smoking status, Healthcare utilisation within preceding nine months

o Psychological and behaviour change measures: Self-efficacy for diabetes management, Illness perceptions, diabetes distress, health related quality of life, perceived social support, and diabetes related self-care Activities.

o Randomisation: Group randomised to, and if randomised to the intervention group, intervention preferences and tailoring questions

Following the baseline visit and completion of Forms Z and A the RA will enter the participant’s registration number on the spreadsheet to activate the randomised allocation sequence. The researcher will open the envelope containing the group allocation and participants will be informed of their treatment allocation. Those randomised to the control group will be asked to continue with their usual activities and will be told that they will be contacted again in 9 months for follow-up assessments.

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Following randomisation those allocated to the intervention will also complete additional questions on Form A which includes:

- Selection of SMS4BG modules: o Core module

Māori Pacific Non-Māori/Pacific

o Insulin o Smoking o Young adult o Lifestyle modules

Exercise Healthy eating Stress management

o Blood glucose monitoring reminders o Foot care o Cardiovascular check reminder

- Tailoring questions o Preferred name o Preferred message delivery time o Motivations for good diabetes management o Key support people o Message timing

Once registration is complete participants randomly allocated to the intervention arm will commence the SMS4BG text message programme. At 3 months and again at 6 months they will be sent a message asking if they would like the messages to stop or to continue and if they choose to continue they will be contacted by phone by the RA to select the modules (where applicable) they would like to receive and the programme continued for an additional three months. The option to continue and their module preferences will be recorded on Form B.

6.9 Follow up measures All participants will be followed-up at 9 months following their baseline assessment (+/- 3 weeks) (Form B) (see Table 2). All participants will be sent a lab form for an HbA1c test to be taken by their usual provider to measure change in glycaemic control. Results will be obtained by clinicians within the DHB/PHOs. Secondary outcomes will be assessed at 9 months using Form B and will the same clinical and psychological measures as at baseline. In addition intervention participants will be asked to complete an exit interview to determine the usability and acceptability of the intervention and system interaction (engagement) data will be obtained. Follow up measures (Form B) are described below:

- Clinical information (obtained from medical records): HbA1c results and dates, Diabetes Foot Screening risk category, Smoking status, Healthcare utilisation during the study period (hospitalisations, primary and secondary care visits)

- Psychological and behaviour change measures: Self-efficacy for diabetes management, Illness perceptions, diabetes distress, health related quality of life, perceived social support, and diabetes related self-care activities.

- Exit Interview (those in intervention arm only): Participant feedback on satisfaction with the programme will include ease of use, issues arising,

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satisfaction with the text messages, salience and usefulness of the messages, messages that should be removed, and suggestions for improvement.

- System interaction (those in intervention arm only – obtained through the system): Interaction with the programme will be measured using opt out rates, responses to text messages, and access to feedback graphs.

To facilitate completion of the follow up assessments participants will be offered a voucher to reimburse them for their time.

6.10 Schedule of intervention and follow-up Participants in the intervention arm will be sent text messages based on their module selection for between 3 to 9 months as per Figure 2. Participants will have the option to text in the word ‘STOP’ to stop the programme at any time but these participants will still be included in the follow up. Participants will also be able to text the word ‘HOLIDAY’ to stop their messages for a one week period to allow for those who go overseas and need to temporarily pause their messages. Some text messages will require a text response, for example the blood glucose monitoring reminder programme. The text responses, on receipt, will be displayed graphically on a secure website for the participant to self-review and identify trends in their management. The participant’s care team will also be able to access and review the graphs. If clinically relevant the participant will be contacted by one of their care team. Printed copies of glucose graphs will be posted monthly to those participants who do not have access to the internet. At the end of the study (month 9 +/- 3 week) all participants will be asked to complete follow up measures over the phone. Their responses will be collated electronically and stored securely at the NIHI. Table 2: Details of follow-up

Timing Description

Baseline During study period (0 – 9

months) 9 months

Eligibility criteria X

Date of birth X

Contact details X

Consent X

Demographics

- Ethnicity X

- Gender X

- Employment status X

- DHB region X

- Postcode X

Clinical measures:

- HbA1c X X X

- Smoking status X X

- Foot risk category X X

- Healthcare utilisation X X

Behaviour/psychological health measures

- Self-efficacy X X

- Distress X X

- Health related quality of life X X

- Diabetes self-care behaviours X X

- Illness perceptions X X

- Social support X X

Module selections*

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- Core module* X X

- Insulin module* X X

- Monitoring module* X X

- Young adult* X X

- Smoking module* X X

- Lifestyle modules* X X

- Foot care module X X

- Cardiovascular check module* X X

Tailoring questions* X

Engagement with intervention* X

Exit interview* X

*intervention participants only

6.11 Detail of contact with participants

6.11.1 Eligibility and consent Either: 1. Potential participants will be contacted via their PHO or DHB to:

- Assess eligibility to take part - Assess interest in taking part in the trial - Obtain permission for details to be passed onto the researchers and for a member of

the research team to contact those who are eligible and wish to take part 2. Potential participants who self-refer to the study will be given information about the study and eligibility checked by the RA 3. Potential participants identified by the clinician in waiting rooms or ward will be given a flyer about the study and asked if they would like to be contacted about the study

6.11.2 Registration A RA will contact all those wishing to take part within 1 week to gain informed consent, complete baseline measures, randomise and if appropriate enrol them for the intervention.

6.11.3 Intervention group: Intervention 3 month extension A RA will contact by phone those intervention group participants who, at 3 months and 6 months, indicate by return text that they wish to continue to receive the intervention for a further 3 months. They will determine and document which modules the participant would like to receive.

6.11.4 Follow up A RA will contact all participants at 9 months to conduct follow up measures.

6.12 Detail of clinical measures

6.12.1 Registration Once informed consent has been obtained the RA will send a request for baseline clinical measures form medical records:

- NHI - Baseline HbA1c result and date - Diabetes type - Diabetes foot screening risk category - Smoking status - Healthcare utilisation within preceding nine months (hospitalisations, primary and

secondary care visits)

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6.12.2 Follow up A clinician at the corresponding DHB/PHO will obtain the following from medical records at follow up:

- HbA1c result and date at 9 months and, if available, at 3 months and 6 months - Diabetes foot screening risk category - Smoking status - Healthcare utilisation within the 9 month study period (hospitalisations, primary and

secondary care visits)

6.13 Sub-study: Waitlist control (SMS4BG-WCS) At 9 months follow up people who were randomly allocated to the control group will be invited to participate in a sub-study where they will receive the SMS4BG intervention following completion of their follow up interview. The aim of this sub-study is to provide further evidence of the effectiveness of SMS4BG to address the aims of the overall study and to inform the DHBs and MOH decisions on whether to scale up and implement the programme across the districts/New Zealand. The sub-study will be a before and after design.

6.13.1 Inclusion criteria: - Participants randomised to the control group of the SMS4BG RCT who complete the

9 month follow up - Available for the 9 month study duration - Provide informed consent

6.13.2 Procedures At the end of the main study follow up (see section 6.10) all eligible participants will be offered the opportunity to take part in the sub-study. If interested the RA will go through the sub-study PIS and consent form. Hard copies of the PIS and consent form will be posted to all interested participants. Participants will be encouraged to discuss their participation with whanau, family and friends. Once verbal informed consent has been given the RA will enrol them in the SMS4BG intervention Participants will be sent text messages based on their module selection for between 3 to 9 months as per Figure 2. Participants will have the option to text in the word ‘STOP’ to stop the programme at any time but these participants will still be included in the follow up. Participants will also be able to text the word ‘HOLIDAY’ to stop their messages for a one week period to allow for those who go overseas and need to temporarily pause their messages. Some text messages will require a text response, for example the blood glucose monitoring reminder programme. The text responses, on receipt, will be displayed graphically on a secure website for the participant to self-review and identify trends in their management. Printed copies of glucose graphs will be posted monthly to those participants who do not have access to the internet. At the end of the sub-study (month 9 +/- 3 week) all participants will be asked to complete follow up measures over the phone. Their responses will be collated electronically and stored securely at the NIHI. Follow up measures will consist of those completed by the intervention arm of the main study:

- Clinical information (obtained from medical records): HbA1c results and dates, Diabetes Foot Screening risk category, Smoking status, Healthcare utilisation during the study period (hospitalisations, primary and secondary care visits)

- Psychological and behaviour change measures: Self-efficacy for diabetes management, Illness perceptions, diabetes distress, health related quality of life, perceived social support, and diabetes related self-care activities.

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- Exit Interview: Participant feedback on satisfaction with the programme will include ease of use, issues arising, satisfaction with the text messages, salience and usefulness of the messages, messages that should be removed, and suggestions for improvement.

- System interaction (obtained through the system): Interaction with the programme will be measured using opt out rates, responses to text messages, and access to feedback graphs

6.13.3 Study outcomes Outcomes measures will be the same utilised in the main SMS4BG RCT. The primary outcome will be the change in HbA1c level from sub-study baseline to 9 months. Secondary outcomes include health behaviours, self-efficacy, diabetes distress, health related quality of life, perceived social support, illness perceptions, engagement/ interaction with the programme and intervention satisfaction and feedback. To reduce participant burden:

- Baseline HbA1c: Will be obtained at the main study 9-month follow up.

- Baseline secondary measures: Obtained from the participants follow up data of the main trial.

- Demographic characteristics: Obtained from the participants baseline data of the main trial.

6.13.4 Analysis The sub-study results will be analysed separately from the main trial results with no data form the sub-study contributing to the main study. Baseline characteristics will be summarised using descriptive statistics. Change in outcome measures will be analysed using t-tests. Thematic analysis will be used to explore the patient satisfaction and feedback.

6.14 Long term follow up Although not possible within the current funding, the long term effect of the intervention on glycaemic control will be important to investigate. It is envisaged that the research team will apply for funding to undertake follow up at 2 years and 5 years to assess whether any differences in the change in HbA1c at 9 months are maintained at 2 years and 5 years.

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7. Statistical Considerations

7.1 Sample size Recruiting 500 participants (250 per arm) in two Auckland DHB regions will provide 90% power at 5% significance level to detect an overall clinically meaningful difference of 0.5% (6 mmol/mol) in change in HbA1c from baseline to 9 months between the two arms, assuming a standard deviation of 1.7%. The same recruitment target (500 participants with 250 per arm) will be set for all non-Auckland DHB/PHO regions, which will provide the same statistical power to evaluate the effect of intervention in areas with high rural and remote populations. The total sample size for the trial will therefore be 1000 participants. As many Māori and Pacific participants as possible will be recruited to allow for subgroup analyses by ethnicity grouping (Maori/Pacific, and non-Maori/Pacific).

7.2 Study outcomes The primary outcome is the change in HbA1c level from baseline to 9 months. Baseline HbA1c will be the result from the latest test at enrolment within the preceding nine months. Secondary outcomes include:

- Glycaemic control as measured by HbA1c at 3 months and 6 months - Self-efficacy as measured by the Stanford Diabetes Self-Efficacy Scale23 - Diabetes self-care behaviours as measured by the Summary of Diabetes Self-Care

Activities24 measure - Diabetes related distress as measured by the Diabetes Distress Screening Scale

(DDS-2)25 - Perceptions and beliefs about diabetes as measured by the Brief Illness Perceptions

Questionnaire (B-IPQ)26 - Health related quality of life as measured by the EQ-5D27 - Perceived social support for diabetes management measured using a 4 item

measure developed for this study - Healthcare utilisation including hospitalisations, and primary and secondary care

visits - For those that are randomised to the intervention group, engagement/ interaction with

the programme - For those that are randomised to the intervention group, satisfaction with the

programme, including ease of use, issues arising, satisfaction with the text messages, salience and usefulness of the messages, and suggestions for improvement

- Cost-effectiveness of the intervention using cost information, including cost of programme, and direct medical costs (including cost of treatment, primary care, secondary care) and Quality Adjusted Life Year (QALY).

7.3 Statistical analysis The final data will be extracted from the central study database into SAS version 9.4 (SAS Institute Inc. Cary NC) for analysis. All statistical tests will be two-sided at 5% level of significance. Data analyses will be specified a priori in the statistical analysis plan prepared by the trial statistician (and agreed upon by all Investigators).

7.3.1 Baseline characteristics Baseline characteristics will be summarised using descriptive statistics. Continuous variables will be described as numbers of observed and missing values, mean, standard deviation, median, minimum and maximum. Categorical variables will be described as frequencies and percentages. Results will be presented for each treatment group as well as overall. Since any

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differences between randomised groups at baseline could only have occurred by chance, no formal significance testing will be conducted.

7.3.2 Intervention effects Treatment evaluation will be performed on the principle of intention-to-treat (ITT), on all participants as the way they were randomised to. The analysis of covariance regression model will be used to test the effect of intervention on the primary outcome between two groups, adjusting for baseline outcome value, diabetes type and ethnicity. The effect of intervention will be evaluated separately for Auckland DHBs and non-Auckland DHBs. Model adjusted means and their difference will be presented with 95% confidence intervals. A similar approach will be used for other continuous secondary outcomes. Generalized linear regression models will be applied to categorical outcomes using an appropriate link function. Subgroups analyses will be conducted by ethnic group (Māori/Pacific, non-Māori/Pacific) and diabetes type (I, II) to test possible interactions with the intervention.

7.3.3 Procedures to account for missing data Missing data on the primary outcome will be imputed using multiple imputations in the main ITT analysis. If the proportion of missing is greater than 10%, sensitivity analyses will be conducted using the imputation methods under different assumptions (including observed data analysis, or last value carry forward) to test the robustness of trial results.

7.3.4 Interim analyses No interim analyses will be undertaken.

7.4 Data safety and monitoring All participants will also continue with their usual diabetes care. No individual clinical advice is given through the pre-programmed text messages. For the purposes of this study, a risk management plan will be developed by the clinical investigators (RC, CM, RM, MK) who will be available should any clinical advice be required. Eligibility criteria will be confirmed by logic checks within NIHI’s electronic data collection and management system. An independent monitor will check consents and review the trial master file. We will not be collecting AEs or SAEs as participants will be continuing with their usual care and none could be expected as a result of the study itself. Although we will be evaluating hospitalisations or health service utilisation as part of the outcomes specified above.

7.5 Data management The design and management of all databases associated with this trial will be undertaken by the data management and IT groups at NIHI. The databases will be constructed using Microsoft Excel 2010 and REDCap, with data entry undertaken by RAs. The Microsoft Excel documents and REDCap database will be located in the secure web-folder which will have restricted access and will also be backed-up on a daily basis to ensure quality of data is maintained.

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8. Ethical Approval and Consent

8.1 National ethics approval Ethical approval will be sought from a Health and Disability Ethics Committee. This study will conform to standards of good clinical research practice (GCP). All participants will receive a participant information sheet and copy of their consent details. Any hard copies of participant data collected will be treated as confidential and stored securely in a locked cabinet at NIHI. Participation in the study is entirely voluntary and maybe withdrawn at any time.

8.2 Informed consent Maintenance of confidentiality and compliance with the Privacy Act will be emphasised to all study participants. Participation in the study will be entirely voluntary. A Patient Information Sheet and Consent Form will be sent to participants who express an interest in the study. Informed consent will be obtained once participants have had the opportunity to ask any questions. Please see Appendix 2 for more information.

9. Safety and Adverse Events There are unlikely to be any risks associated with this research.

9.1 Unblinding This study will not be blinded.

9.2 Data safety and monitoring Ellenburg et al. (2002) provide guidelines for deciding whether or not a Data Safety and Monitoring Committee (DMC) needs to be established for a trial. They propose that if two or more of the following criteria are met then a DMC is required.

1. The trial is intended to provide definitive information about the effectiveness and/or safety of a medical intervention.

2. There are prior data to suggest that the intervention being studied has the potential to induce potentially unacceptable toxicity.

3. The trial is evaluating mortality or another major endpoint such that inferiority of one treatment arm has safety as well as effectiveness implications.

4. It would be ethically important for the trial to stop early if the primary question addressed has been definitively answered, even if secondary questions or complete safety information were not fully addressed.

The proposed SMS4BG study does not meet two or more of the above criteria. Consequently, a DMC will not be established for the trial.

10. Clinical Supplies No clinical supplies are used in this study.

11. Relevance to Health Addressing increasing diabetes prevalence, its associated morbidity and health inequalities, is a current priority for New Zealand. Self-management including monitoring glucose levels and frequent healthcare provider contact are associated with glycaemic control and even small improvements in glycaemic control are associated with a reduction in long-term complications. In light of increasing mobile phone ownership across cultural and socio-economic groups, we hypothesize that technology-based tools are important options for self-

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management support in this population. The National Institute for Health Innovation (NIHI) and WDHB have co-developed and piloted a mobile phone based text messaging programme to enhance self-management in people with diabetes (SMS4BG). This randomised controlled trial of the effectiveness of SMS4BG will inform the decision on whether to scale up and implement the programme across New Zealand

12. Dissemination of Results

12.1 Study participants At the end of the programme, all participants will receive a brief summary of the project results, an outline of their significance and any associated future programmes or plans.

12.2 The general public The general public will be informed about the trial via local media coverage as appropriate.

12.3 Academic/professional colleagues Academic and professional colleagues will be informed about the project via articles submitted to high-impact peer-reviewed journals if appropriate. Opportunities to make oral presentations to local, national and international audiences will also be actively pursued.

12.4 Health service funders and providers Stakeholders who have contributed to the planning and scoping phase of this project will be informed of the project outcomes. Reports will be provided to HRC as per the contract. The wider network of health service funders and providers will be kept informed about the project via presentations at conferences as relevant.

12.5 Iwi/ Māori Māori will be informed of progress with the trial using Māori health networks and contacts. The Māori Research Advisory Committee of the NIHI, Auckland and Waitemata Hospitals will advise the research group on other appropriate methods of dissemination of information to Māori. As co-investigator Dr Matt Shepherd (Ngati Tama) will ensure the intervention development and implementation, conduct of the trial, and interpretation of the findings are responsive to Māori and conform to a Māori world view. The NIHI’s Māori Research Advisory Committee, will provide support and advice on: relevance to Māori, engagement with Māori stakeholders, processes to inform Māori health development, and appropriate dissemination pathways.

12.6 Pacific Island communities Pacific island communities will be consulted through local health workers via the respective hospitals and through University of Auckland networks. Progress of the trial and final results will be disseminated via relevant fono.

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13. Administrative Section

13.1 Adherence to the protocol Except for a change that is intended to eliminate an immediate hazard to participants, the approved protocol will be conducted as described. Any significant protocol deviation will be documented appropriately.

13.2 Protocol revision procedures All revisions will be discussed with, and approved by, the Project Management Committee. If the revision is an “administrative letter”, the principal investigator will submit it to the appropriate Ethics Committee for their information. The principal investigator will submit any amendments to the appropriate Ethics Committee for review and approval or favourable opinion prior to implementation. Ethics correspondence will be filed in the Trial Master File and copies where appropriate will be sent to sites. If an amendment substantially alters the study design or increases the potential risk to the subject:

• the consent form will be revised and submitted to the Ethics Committee for review and approval or favourable opinion;

• participants currently enrolled in the study, if they are affected by the amendment, will be contacted by telephone and the amendment discussed and verbal consent re-obtained;

• the revised consent form will be posted to participants currently enrolled in the study if they are affected by the amendment;

13.3 Form procedures Paper CRFs (if used) will be completed legibly in black ink at the time of each participant call. Corrections will be made in the following manner: a single line will be drawn through the incorrect entry and the correct information will be written adjacent to the incorrect entry. The correction will be initialled and dated by the person making the correction. Once completed, all paper forms will be entered electronically as soon as possible, then filed in the designated project folder held at NIHI. For both paper and electronic forms, participants will be identified by their study ID, initials and birth date. All requested information will be entered on the CRF in the spaces provided. If an item is not available it will be documented with an asterisk (‘*’). If an item is not applicable it will be documented with a dash (‘-’). Blank spaces will not be permitted. All forms (paper and electronic) will be checked for missing data or errors. Validation ranges will be set up on the web-based CRFs to ensure electronic notification of any numeric values outside of set ranges. At the end of the project an adjudication committee will review all free text fields within the forms, to look for key themes to summarise the data.

13.4 Monitoring/ Source document verification An independent project monitor will be appointed. The monitor will be trained in GCP. The project is considered to be low risk. The monitor will check primary outcome measures, and TMF and consent forms for completeness and accuracy. The Project Manager will check and validate at least 10% of data in the electronic system against the source document (where a hard copy exists).

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If logic checks then monitor doesn’t need to check.

13.5 Data confidentiality and security Information about study subjects will be kept confidential in keeping with the obligations set out in the Privacy Act 1993, the Health Information Code 1994 and Section 22B to 221 of the Health Act 1956. Data will be entered, stored and backed-up in a secure manner on a server at the National Institute for Health Innovation. Confidentiality will be protected by the use of study registration numbers, and only aggregated and anonymous data will be reported. Personal information will be kept confidential and stored securely. Computerised information will be password protected. All reports from the study will be written in a way that no individuals can be identified.

13.6 Reporting schedule Reports will be submitted to HRC according to the schedule detailed in the contract.

13.7 Record retention policy The Principal Investigator will retain copies of paper forms (or electronic files), and source documents for the maximum period required by the Privacy Legislation and the Health (Retention of Health Information) Regulations 1996 (15 years from date of termination of study). If the principal investigator or any co-investigators withdraw from the study (e.g. relocation, retirement), any records they hold will be transferred to a mutually agreed upon designee (e.g. another co-investigator). Notice of such transfer will be given in writing to the NIHI.

13.8 Insurance Participants may be considered for coverage under accident compensation legislation, for any injury caused as a result of their participation in this research.

13.9 Ownership of data and publication policy Individual project data will remain the property of individual project participants. The NIHI will have the responsibility for storage, protection and retrieval of project data. The Project Management Committee will have the responsibility for the safe guardianship and use of the data. All access, analyses and dissemination of Māori-specific data will be the joint responsibility of the Project Management Committee and the NIHI Māori Advisory Committee. All publications will be approved by members of the Project Management Committee, who will be named on all reports. Participants, staff at Recruitment Centres and study sponsors will be acknowledged in the final report and in all publications and presentations resulting from this project.

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14. Study Acknowledgement

STUDY ACKNOWLEDGMENT I have read the protocol and agree that it contains all necessary details for carrying out the study as described. I will conduct this protocol as outlined therein and will make a reasonable effort to complete the study within the time designated. I will provide copies of the protocol and access to all information to study personnel under my supervision. I will discuss this material with them to ensure that they are fully informed about the treatment and the study. I understand that the study may be terminated or enrolment suspended at any time if it becomes necessary to protect the best interests of the study participants. ______________________________________ ________________ Investigator's printed name and signature Date Address of study site:

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15. References 1. Hotu S, Carter B, Watson P, Cutfield W, Cundy T. Increasing prevalence of type 2 diabetes in

adolescents. J Paediatr Child Health. 2004;40(4):201-4. 2. Ministry of Health [Internet]. 2012. Virtual Diabetes Register. 3. Ministry of Health. Diabetes and Cardiovascular Disease Quality Improvement Plan.

Wellington: Ministry of Health, 2008. 4. Morrison F, Shubina M, Turchin A. Encounter frequency and serum glucose level, blood

pressure, and cholesteral level control in patients with diabetes mellitus. Archives of Internal Medicine. 2011;171(17):1542-50.

5. Karter AJ, Ackerson LM, Darbinian JA, D’Agostino Jr RB, Ferrara A, Liu J, et al. Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. American Journal of Medicine. 2001;111(1):1-9.

6. Bailey TS, Zisser HC, Garg SK. Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study. Diabetes technology & therapeutics. 2007;9(3):203-10.

7. Cho J-H, Chang S-A, Kwon H-S, Choi Y-H, Ko S-H, Moon S-D, et al. Long-Term Effect of the Internet-Based Glucose Monitoring System on HbA1c Reduction and Glucose Stability A 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006;29(12):2625-31.

8. Statistics New Zealand. Household use of information and communication technology: 2009. In: Zleanad SN, editor. 2010.

9. Commerce Commision New Zealand. Annual Telecommunications Monitoring Report 2012. 2013 April 2013. Report No.

10. Cole-Lewis H, Kershaw T. Text messaging as a tool for behavior change in disease prevention and management. Epidemiologic reviews. 2010;32(1):56-69.

11. Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemedicine and e-Health. 2009;15(3):231-40.

12. Whittaker R, Borland R, Bullen C, Lin RB, McRobbie H, Rodgers A. Mobile phone-based interventions for smoking cessation. Cochrane Database Systematic Rev. 2009;4.

13. Liang X, Wang Q, Yang X, Cao J, Chen J, Mo X, et al. Effect of mobile phone intervention for diabetes on glycaemic control: a meta-analysis. Diabetic Medicine. 2011;28(4):455-63.

14. Holtz B, Lauckner C. Diabetes management via mobile phones: a systematic review. Telemedicine and e-Health. 2012;18(3):175-84.

15. Russell-Minda E, Jutai J, Speechley M, Bradley K, Chudyk A, Petrella R. Health technologies for monitoring and managing diabetes: a systematic review. Journal of diabetes science and technology. 2009;3(6):1460.

16. Blake H. Mobile phone technology in chronic disease management. Nursing standard. 2008;23(12):43-6.

17. Riley WT, Rivera DE, Atienza AA, Nilsen W, Allison SM, Mermelstein R. Health behavior models in the age of mobile interventions: are our theories up to the task?: Springer; 2011.

18. Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, et al. The Effectiveness of Mobile-Health Technology-Based Health Behaviour Change or Disease Management Interventions for Health Care Consumers: A Systematic Review. PLoS Med. 2013;10(1):e1001362.

19. Whittaker R, Merry S, Dorey E, Maddison R. A development and evaluation process for mHealth interventions: Examples from New Zealand. Journal of health communication. 2012;17(sup1):11-21.

20. Bandura A. Human agency in social cognitive theory. American Psychologist. 1989;44:1175-84.

21. Leventhal H, Brissette I, Leventhal EA. The common-sense model of self-regulation of health and illness. The self-regulation of health and illness behaviour. 2003;1:42-65.

22. Dobson, R. Carter, K. Cutfield, R. Hulme, A. Hulme, R. McNamara, C. Maddison, R. Murphy, R. Shepherd, M, Strydom, S. Whittaker, R. Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study. Submitted

23. Lorig K, Ritter PL, Villa FJ, Armas J. Community-Based Peer-Led Diabetes Self-Management: A Randomized Trial. The Diabetes Educator 2009; Jul-Aug;35(4):641-5

24. Toobert, D. J., Hampson, S. E., & Glasgow, R. E. The Summary of Diabetes Self-Care Activities Measure: Results from 7 studies and a revised scale. Diabetes Care 2000, 23, 943-950

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25. Fisher, Lawrence, et al. "Development of a brief diabetes distress screening instrument." The Annals of Family Medicine 6.3 (2008): 246-252.

26. Broadbent, E., Petrie, K.J., Main, J., & Weinman, J. The Brief Illness Perception Questionnaire (BIPQ). Journal of Psychosomatic Research 2006, 60, 631-637

27. EuroQol Group. EuroQol–a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199–208

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16. Appendix 1 – Terms of Reference

16.1 Project Management Committee The Project Management Committee will be responsible for the daily operation of the study, and will develop study materials, deal with study problems, recruitment, and logistical issues. Meetings will be held monthly while the study is in development, then as required when the study is underway.

16.2 Trial Steering Committee The Trial Steering Committee will consist of all study investigators and will be responsible for providing strategic guidance for the trial including developing and maintaining the study design, approval of the protocol, statistical analysis, presentation and publication of results. The Committee will meet as required throughout the study.

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17. Appendix 2 – Informed Consent Procedures and Forms

17.1 Informed consent Verbal consent will be obtained from ALL participants over the phone. For consent to be valid the participant must be suitably informed of the study including risks and any benefits to them. This is to enable them to make an independent choice about whether to participate. Each participant will be posted the consent form and patient information sheet immediately after enrolment. Participants will be asked to sign and date the consent form when they receive it and keep it for their own reference. Issues to be covered in the information sheet will be reviewed carefully with each participant. It will not be assumed that every person has read the information sheet or that they can read. The potential participant will be given details (refer information sheet) regarding:

• The purpose of the study.

• An explanation of who the researchers are.

• An explanation of why the participant qualifies for the study.

• The type of participants studied and the number likely to be involved.

• The length of the study.

• The length of time and the procedure of the assessment, interventions, including the biochemical tests.

• The potential risks/benefits to the person. The potential participant will be informed (refer information sheet) that:

• The supply of information provided by them is entirely voluntary.

• They may refuse to answer any of the questions. They do not have to give a reason for doing so.

• They have the right to access their data and/or to remove it from the study.

• They have the right to have questions answered.

• A person outside of the study is available to be contacted should they have any concerns i.e. a health advocate.

The participant will be made aware (refer information sheet) that:

• Personal information will be collected about them but that this information will be kept strictly confidential.

• That paper copies of this information may be completed and will be kept securely at the NIHI.

• All computerised information will be password protected on a computer.

• No one, other than the study investigators and people that may audit the data (e.g. the study monitor, relevant regulatory bodies, and the trial sponsors) will have access to these data.

• All information will be published or presented in a way that no individual can be identified. The fact that the participant has given (or declined) consent will be recorded on the computer programme at the time of enrolment. Note that consent to participate is usually an entry criteria in NIHI studies.

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18. Appendix 3 – Proposed Timeline The timeline for the project is:

Study set up Recruitment Intervention Follow up Data

analysis Dissemination

of results

2014

Oct

Nov

Dec

2015

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sept

Oct

Nov

Dec

2016

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sept

Oct

Nov

Dec

2017

Jan

Feb

Mar

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Key milestones Date Milestone January 2015 Ethics approval June 2015 Recruitment begins June 2015 Data collection starts March 2016 Recruitment completed December 2016 Follow-up data collection completed January 2017 Data lock March 2017 Analysis and report writing completed March 2017 Dissemination begins

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19. Appendix 4 – Declaration of Helsinki See: http://www.wma.net/en/30publications/10policies/b3/index.html WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added) 55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added) 59th WMA General Assembly, Seoul, October 2008

6. INTRODUCTION

6. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs.

6. Although the Declaration is addressed primarily to physicians, the WMA encourages

other participants in medical research involving human subjects to adopt these principles.

6. It is the duty of the physician to promote and safeguard the health of patients,

including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

6. The Declaration of Geneva of the WMA binds the physician with the words, “The

health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

6. Medical progress is based on research that ultimately must include studies involving

human subjects. Populations that are underrepresented in medical research should be provided appropriate access to participation in research.

6. In medical research involving human subjects, the well-being of the individual

research subject must take precedence over all other interests. 7. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

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8. In medical practice and in medical research, most interventions involve risks and burdens. 9. Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence. 10. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration. B. PRINCIPLES FOR ALL MEDICAL RESEARCH 11. It is the duty of physicians who participate in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. 12. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected. 13. Appropriate caution must be exercised in the conduct of medical research that may harm the environment. 14. The design and performance of each research study involving human subjects must be clearly described in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, incentives for subjects and provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. The protocol should describe arrangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other appropriate care or benefits. 15. The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee. 16. Medical research involving human subjects must be conducted only by individuals with the appropriate scientific training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional. The responsibility for the protection of research subjects must always rest with the physician or other health care professional and never the research subjects, even though they have given consent.

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17. Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research. 18. Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation.

6. Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.

6. Physicians may not participate in a research study involving human subjects unless

they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when the risks are found to outweigh the potential benefits or when there is conclusive proof of positive and beneficial results.

6. Medical research involving human subjects may only be conducted if the importance

of the objective outweighs the inherent risks and burdens to the research subjects. 22. Participation by competent individuals as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no competent individual may be enrolled in a research study unless he or she freely agrees. 23. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity. 24. In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. 25. For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse. There may be situations where consent would be impossible or impractical to obtain for such research or would pose a threat to the validity of the research. In such situations the research may be done only after consideration and approval of a research ethics committee. 26. When seeking informed consent for participation in a research study the physician should be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship.

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27. For a potential research subject who is incompetent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent persons, and the research entails only minimal risk and minimal burden. 28. When a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject’s dissent should be respected. 29. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative. 30. Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE 31. The physician may combine medical research with medical care only to the extent that the research is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects. 32. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

• The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

• Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.

33. At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.

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34. The physician must fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never interfere with the patient-physician relationship. 35. In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.

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20. Appendix 5 – Summary of Protocol Amendments

Page Section heading Amendment

17 6.6 Study intervention Table 1: Description of blood glucose monitoring module updated to include “In addition informational messages around managing hypos”

19 6.8 Baseline assessments

Form A has been split into 2 forms with the “Contact Details” section being moved to Form Z and the remaining sections comprising Form A

“Clinical information (obtained from medical records” changed to “Clinical information (obtained from referrer and medical records” to clarify that some of the information is coming from the referrer

“NHI” Added to information obtained under “Clinical Information” to ensure correct linking of information

“(Hospitalizations, primary and secondary care visits)” removed from clinical information bullet point

Description of “Psychological and behaviour change measures” wording simplified

20 6.9 Follow up measures Description of “Psychological and behaviour change measures” wording simplified

22 6.11.1 Eligibility and consent

Further clarified. “Obtain permission for a member of the research team to contact those who are eligible and wish to take part” updated to “Obtain permission for details to be passed onto the researchers and for a member of the research team to contact those who are eligible and wish to take part”

6.12.1 Registration Simplified. “Once informed consent has been obtained the RA will send a request to source baseline clinical measures form medical records” updated to “Once informed consent has been obtained the RA will send a request for baseline clinical measures form medical records:”

NHI added to list

6.12.2 Follow up “Site” changed to “DHB/PHO”

23 7.2 Study Outcomes Simplified descriptions of secondary outcomes

EQ-5D measure added to assess health related quality of life

Diabetes Distress Measure changed to Diabetes Distress Screening measure to reduce participant burden

11 Overview: Study outcomes

Added “health related quality of life” to list of secondary outcomes

ALL Header Version number updated: SMS4BG RCT 2014 Protocol – Version 2.0

ALL Footer Date updated to 26/11/2014

1 ANZCTR ANZCTR number added: ACTRN12614001232628

31 References Reference list updated

7 Signature page Latest version of protocol entered into list

Authors updated to included Rosie Dobson


Description of “Psychological and behaviour change measures” edited to include perceived social support

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20 6.9 Follow up measures Description of “Psychological and behaviour change measures” edited to include perceived social support

34 18. Appendix 3 – Proposed Timeline

Updated to reflect new start date for recruitment of January 2015

23 7.2 Study Outcomes Perceived social support added to secondary outcomes

11 Overview: Study outcomes

Added “perceived social support” to list of secondary outcomes

ALL Header Version number updated: SMS4BG RCT 2014 Protocol – Version 3


6 Project Sponsors Updated to include Ministry of Health as a primary sponsor of the study

10-11 Overview Study period, objectives, study duration, study design and methodology, Sample size, Statistical analysis and Funding sections updated

12 Study flow diagrams Sample size updated in Figure 1 to 500 per arm Sample size updated in Figure 2

16 Rationale for present study

Feedback from the SMS4BG pilot study has allowed for further development and refinement of SMS4BG to be undertaken. While the pilot study yielded positive results a larger scale randomised controlled trial of the effectiveness of SMS4BG is now required to inform the DHB’s decision on whether to scale up and implement the programme across the districts. Updated to: Feedback from the SMS4BG pilot study has allowed for further development and refinement of SMS4BG to be undertaken. While the pilot study yielded positive results a larger scale randomised controlled trial (RCT) of the effectiveness of SMS4BG is now required including the effectiveness of SMS4BG in DHB districts with high rural and remote populations. The findings from this RCT will inform the decision on whether to scale up and implement the programme across New Zealand.

16 Study objectives New objective added: “Assess effectiveness of SMS4BG in DHB/PHO’s with high rural/remote populations”

Recruitment and Baseline Data Collection

Non-Auckland DHB regions added

17 Randomisation Following baseline data collection, eligible participants will be randomised to either intervention or control group in a 1:1 ratio and stratified by diabetes type (1 or 2) and ethnicity (Māori & Pacific, or non-Māori & non-Pacific). The randomisation sequence will be generated by computer program and allocation concealed in consecutively numbered sealed envelopes. Updated to: Following baseline data collection, eligible participants will be randomised to either intervention or control group in a 1:1 ratio and stratified by DHB region (Auckland or non-Auckland), diabetes type (1 or 2), and ethnicity (Māori & Pacific, or non-Māori & non-Pacific). The randomisation

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sequence will be generated by computer program and allocation concealed until the point of randomisation.

Blinding Added: “Although it will not be possible for research staff to be blinded to the treatment allocation the key health outcome HbA1c is not subject to bias.”

19 Baseline assessments Form A, employment status, postcode and DHB region added to demographic information

21 Schedule of intervention and follow-up

Table 2: Details of follow up, DHB region, postcode, and social support added

24 7.1 Sample size 500 participants (250 per arm) will be required to detect an overall clinically meaningful difference of 0.5% (6mmol/mol) in change in HbA1c7 in intervention participants compared with control participants (with 90% power at 5% significance level, using a standard deviation of 1.7%). Aiming for as many Māori and Pacific participants as possible, will allow us to undertake important subgroup analyses.” Updated to: Recruiting 500 participants (250 per arm) in two Auckland DHB regions will provide 90% power at 5% significance level to detect an overall clinically meaningful difference of 0.5% (6 mmol/mol) in change in HbA1c from baseline to 9 months between the two arms, assuming a standard deviation of 1.7%. The same recruitment target (500 participants with 250 per arm) will be set for all non-Auckland DHB/PHO regions, which will provide the same statistical power to evaluate the effect of intervention in areas with high rural and remote populations. The total sample size for the trial will therefore be 1000 participants. As many Māori and Pacific participants as possible will be recruited to allow for subgroup analyses by ethnicity grouping (Maori/Pacific, and non-Maori/Pacific).

25 7.3.2 Intervention effects

Treatment evaluation will be performed on the principle of intention-to-treat (ITT), on all participants as the way they were randomised to. The analysis of covariance regression model will be used to test the effect of intervention on the primary outcome between two groups, adjusting for baseline outcome value and stratification factors (diabetes type and ethnicity). Model adjusted means and their difference will be presented with 95% confidence intervals. A similar approach will be used for other continuous secondary outcomes. Generalized linear regression models will be applied to categorical outcomes using an appropriate link function. If enough participants will be recruited, subgroups analyses by diabetes type and ethnic groups will be conducted to test possible interactions with the intervention. Updated to: Treatment evaluation will be performed on the principle of intention-to-treat (ITT), on all participants as the way they were randomised to. The analysis of covariance regression model will be used to test the effect of intervention on the primary outcome between two groups, adjusting for baseline

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outcome value, diabetes type and ethnicity. The effect of intervention will be evaluated separately for Auckland DHBs and non-Auckland DHBs. Model adjusted means and their difference will be presented with 95% confidence intervals. A similar approach will be used for other continuous secondary outcomes. Generalized linear regression models will be applied to categorical outcomes using an appropriate link function. Subgroups analyses will be conducted by ethnic group (Māori/Pacific, non-Māori/Pacific) and diabetes type (I, II) to test possible interactions with the intervention.

25 7.3.3 Procedures to account for missing data

Missing data will be imputed in the primary analysis using multiple imputations method. If the proportion of missing is greater than 10%, sensitivity analyses will be considered on the primary outcome using different imputation strategies. Updated to: Missing data on the primary outcome will be imputed using multiple imputations in the main ITT analysis. If the proportion of missing is greater than 10%, sensitivity analyses will be conducted using the imputation methods under different assumptions (including observed data analysis, or last value carry forward) to test the robustness of trial results.

26 11 Relevance to Health “the districts” changes to “New Zealand”


Timeline and key milestones updated

24 Data management

The design and management of all databases associated with this trial will be undertaken by the data management and IT groups at NIHI. The databases will be constructed using Microsoft Excel 2010 and Oracle 11g, with data entry undertaken by RAs. The Microsoft Excel documents and Oracle 11g database will be located in the secure web-folder which will have restricted access and will also be backed-up on a daily basis to ensure quality of data is maintained Updated to: The design and management of all databases associated with this trial will be undertaken by the data management and IT groups at NIHI. The databases will be constructed using Microsoft Excel 2010 and REDCap, with data entry undertaken by RAs. The Microsoft Excel documents and REDCap database will be located in the secure web-folder which will have restricted access and will also be backed-up on a daily basis to ensure quality of data is maintained

17 6.6 Study Intervention Updated ‘Description of SMS4BG modules’ table with latest messages.




10 Study design and methodology

Recruitment will take place via primary care (Primary Care Organisations (PHOs)) or secondary care services across

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two Auckland DHB regions (Auckland District Health Board (ADHB) and Waitemata District Health Board (WDHB)) and non-Auckland DHB/PHO regions with high rural and remote populations. Potentially eligible people will be invited to participate via 1) their DHB diabetes service or Primary Healthcare Organisation (PHO), or 2) flyers distributed through diabetes networks and if interested a trained research assistant (RA) will obtain consent and collect baseline data by phone. Updated to: Recruitment will take place via primary care (Primary Care Organisations (PHOs)) or secondary care services across two Auckland DHB regions (Auckland District Health Board (ADHB) and Waitemata District Health Board (WDHB)) and non-Auckland DHB/PHO regions with high rural and remote populations. Potentially eligible people will be invited to participate via 1) their DHB diabetes service or Primary Healthcare Organisation (PHO), or 2) flyers distributed through diabetes networks and if interested a trained research assistant (RA) will obtain consent and collect baseline data by phone.

10 Study Population People with Type 1 or Type 2 diabetes, who have had a HbA1c >65mmol/mol within the past 3 months, have a mobile phone, and are able to provide informed consent. Updated to: People with Type 1 or Type 2 diabetes, who have had a HbA1c >65mmol/mol within the past 9 months, have a mobile phone, and are able to provide informed consent.

11 Main criteria for inclusion “Aged 16 – 70 years” updated to “Aged 16 years or older” “Have an HbA1c>65mmol/mol within the preceding 3 months” updated to ““Have an HbA1c>65mmol/mol within the preceding 9 months”

12 Study flow diagrams Screening section of Figure 2 updated

16 6.1 Inclusion criteria “Aged 16 – 70 years” updated to “Aged 16 years or older” “Have an HbA1c>65mmol/mol within the preceding 3 months” updated to ““Have an HbA1c>65mmol/mol within the preceding 9 months”

16 6.3 Recruitment and Baseline Data Collection

The study will take place within two Auckland DHB regions (WDHB and ADHB) and non-Auckland DHB/PHO regions with high rural and remote populations). Recruitment processes will build on those used successfully in the pilot study. Investigators will work with DHB diabetes services and PHO’s to identify and inform potentially eligible patients and establish appropriate processes for contacting them. This will happen through 3 different methods: 1) Potentially eligible people will be invited to participate by their clinician and details sent to NIHI, 2) Potentially eligible people in wards or waiting rooms identified by their clinician will be given a flyer about the study, or 3) Potential participants will be able to self-refer to the study. The RAs at NIHI will contact

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interested and eligible participants by phone to inform them about the study and gain informed consent. Those who provide verbal informed consent will complete baseline data collection by phone with the RA. The RA will complete and send a hard copy of the consent form to each participant. The consent form will note that consent was given verbally by the participant on the appropriate date. NIHI will retain a copy of the consent form. Updated to: The study will take place within two Auckland DHB regions (WDHB and ADHB) and non-Auckland DHB/PHO regions with high rural and remote populations). Recruitment processes will build on those used successfully in the pilot study. Investigators will work with DHB diabetes services and PHO’s to identify and inform potentially eligible patients and establish appropriate processes for contacting them. This will happen through 3 different methods: 1) Potentially eligible people will be invited to participate by their clinician and details sent to NIHI, 2) Potentially eligible people in wards or waiting rooms identified by their clinician will be given a flyer about the study, or 3) Potential participants will be able to self-refer to the study. The RAs at NIHI will contact interested and eligible participants by phone to inform them about the study and gain informed consent. Those who provide verbal informed consent will complete baseline data collection by phone with the RA. The RA will complete and send a hard copy of the consent form to each participant. The consent form will note that consent was given verbally by the participant on the appropriate date. NIHI will retain a copy of the consent form.


Added: Alternatively participants who have heard about the study through flyers, clinicians of diabetes networks will can self-refer to the study. Following explanation of the study the participant’s eligibility will be checked before proceeding with the PIS and consent form.

Baseline HbA1c will be the result from the latest test at enrolment within the preceding three months. Updated to: Baseline HbA1c will be the result from the latest test at enrolment within the preceding nine months.

22 6.11.1 Eligibility and consent

Potential participants will be contacted via their PHO or DHB to:

- Assess eligibility to take part - Assess interest in taking part in the trial - Obtain permission for details to be passed onto the

researchers and for a member of the research team to contact those who are eligible and wish to take part

Updated to: Either:

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1. Potential participants will be contacted via their PHO or DHB to:

- Assess eligibility to take part - Assess interest in taking part in the trial - Obtain permission for details to be passed onto the

researchers and for a member of the research team to contact those who are eligible and wish to take part

2. Potential participants who self-refer to the study will be given information about the study and eligibility checked by the RA 3. Potential participants identified by the clinician in waiting rooms or ward will be given a flyer about the study and asked if they would like to be contacted about the study

24 7.2 Study outcomes Baseline HbA1c will be the result from the latest test at enrolment within the preceding three months. Updated to Baseline HbA1c will be the result from the latest test at enrolment within the preceding nine months.

10 Study design and methodology

Recruitment will take place via primary care (Primary Care Organisations (PHOs)) or secondary care services across two Auckland DHB regions (Auckland District Health Board (ADHB) and Waitemata District Health Board (WDHB)) and non-Auckland DHB/PHO regions with high rural and remote populations. Updated to: Recruitment will take place via primary care (Primary Care Organisations (PHOs)) or secondary care services across Auckland DHB/PHO regions (Auckland District Health Board (ADHB), Waitemata District Health Board (WDHB) and Counties Manukau District Health Board (CMDHB)) and non-Auckland DHB/PHO regions with high rural and remote populations.

16 6.3 Recruitment and Baseline Data Collection

The study will take place within two Auckland DHB regions (WDHB and ADHB) and non-Auckland DHB/PHO regions with high rural and remote populations). Updated to: The study will take place within three Auckland DHB regions (WDHB, CMDHB, and ADHB) and non-Auckland DHB/PHO regions with high rural and remote populations).


Proposed timeline updated to reflect extended recruitment period

36 Key milestones Key milestones updated to reflect extended recruitment period




23 6.13 Sub-study: Waitlist control (SMS4BG-WCS)

Section added

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SMS4BG RCT Version: 3, IC 27/02/2015 1 of 2

SMS4BG:

Diabetes Text Message Support Study

I have read, or have had read to me in my first language, and I understand the Participant Information Sheet.

I have been given sufficient time to consider whether or not to participate in this study.

I have had the opportunity to discuss this study with study researchers and I am satisfied with the answers I have been given.

I have had the opportunity to use a legal representative, whanau/ family support or a friend to help me ask questions and understand the study.

I am satisfied with the answers I have been given regarding the study.

I understand that a copy of this consent form will be mailed to me and that I have the right to withdraw consent after discussion with friends, family, whanau by contacting the researchers.

I understand that taking part in this study is voluntary (my choice) and that I may withdraw from the study at any time without this affecting my medical care.

I consent to the research staff collecting and processing my information, including information about my health.

If I decide to withdraw from the study, I agree that the information collected about me up to the point when I withdraw may continue to be processed.

I agree for the researchers to have access to my hospital and/or primary care medical records to obtain my laboratory test results and health information related to this study.

I understand that any data collected as part of this study will be stored securely for 15 years at the National Institute for Health Innovation, The University of Auckland, in accordance with the Privacy Act, 1994. After this time the information will be safely destroyed.

I agree to an approved auditor appointed by the New Zealand Health and Disability Ethics Committees, National Institute for Health Innovation or any relevant regulatory authority or their approved representative reviewing my relevant medical records for the sole purpose of checking the accuracy of the information recorded for the study.

I understand that my participation in this study is confidential and that no material, which could identify me personally, will be used in any reports on this study.

I understand that the results of the study will be published in medical journals but none of these publications will contain information about me personally.

National Institute for Health Innovation The University of Auckland Level 4, School of Population Health Tamaki Campus, Morrin Road, Glen Innes Private Bag 92019 Auckland NEW ZEALAND Telephone: 64 9 373 7599 Facsimile: 64 9 373 1710 Email: [email protected] www.nihi.auckland.ac.nz

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SMS4BG RCT Version: 3, IC 27/02/2015 2 of 2

I understand that there may be a significant delay between data collection and publication of the results.

I understand the compensation provisions in case of injury during the study.

I know who to contact if I have any questions about the study in general.

I understand my responsibilities as a study participant and agree to be contacted for an interview at the end of the 9 month study period.

Verbal declaration by participant: I agree with all the statements above and hereby consent to take part in this study.

Participant’s full name: Date:

I wish to receive a summary of the results from the study. Yes / No

Declaration by member of research team: I have given a verbal explanation of the research project to the participant, and have answered the participant’s questions about it. I believe that the participant understands the study and has given informed consent to participate.

Researcher’s name:

Researcher’s contact number:

Signature: Date:

Once copy of the completed consent form is to be mailed to the participant and the second completed consent form is to be placed in the trial record file.

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SMS4BG RCT – Version4, PIS, 16/09//2015 1 of 3

Participant Information

SMS4BG:

Diabetes Text Message Support Study

National Institute for Health Innovation The University of Auckland Level 4, School of Population Health Tamaki Campus, Morrin Road, Glen Innes Private Bag 92019 Auckland NEW ZEALAND Telephone: 64 9 373 7599 Facsimile: 64 9 373 1710 Email: [email protected] www.nihi.auckland.ac.nz

You are invited to take part in the SMS4BG study that will help us evaluate whether a text message programme delivered by mobile phone is effective in supporting people with

diabetes. To help you decide if you want to take part in the study, please read this information sheet. Please take your time to think about the information provided below and

feel free to discuss it with your whanau, family or significant other support people before deciding whether to take part. Taking part is completely voluntary (your choice). If you have

any questions you can contact the researchers at any time.

Who is co-ordinating this study? The study is co-ordinated by the National Institute for Health Innovation (The University of Auckland) and is funded by the Health Research Council, in partnership with Waitemata and Auckland District Health Boards, and by the Ministry of Health. What is the aim of this study? The aim of the study is to evaluate whether a text message programme delivered by mobile phone is effective in supporting people with diabetes.

About this study: We plan to recruit 1000 people to take part in the 9 month study. At the start of the study and again 9 months later you will be required to complete questions over the phone with a researcher at a time that suits you. If you agree to take part in the study, you will be randomly allocated (like the toss of a coin) to one of two groups:

- Intervention group: Everyone in this group will receive a personalised text message programme to support them to manage their diabetes for 3 to 9 months. Everyone in this group will be encouraged to continue with their usual diabetes care and medical appointments.

- Control group: Everyone in this group will be encouraged to continue with their usual diabetes care and medical appointments.

What will my participation in the study involve? A researcher will contact you by phone to check your eligibility, answer any questions and obtain verbal consent. We encourage you to talk to your family, whanau and friends about taking part before you make a decision however you can withdraw at any time. We will post you a copy of the consent form for you to keep. To help confirm your eligibility we will obtain a copy of your most recent HbA1c test result from your medical records (through your hospital or PHO). You will also be asked questions about yourself, your diabetes and how you manage your diabetes. This should take about 20-30 minutes.

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http://www.nihi.auckland.ac.nz/



At the end of the study you will be contacted again by phone for another interview. We will ask questions about your diabetes and how you manage it. This should also take around 20-30 minutes.

Phone interview

Study start Study end

How long will it take? 20-30 minutes 20-30 minutes

Study explained, verbal consent obtained

Inclusion and exclusion criteria checked

Questions about your lifestyle and diabetes related behaviors

Intervention group only: Feedback on the intervention

We are interested in whether taking part in this study affects your blood glucose control and how much you use healthcare services. Therefore at the end of the study you will be sent a lab test form for you to have an HbA1c test (glucose blood test). We will also obtain, from your medical records, your HbA1c test results and healthcare utilisation (e.g. number of GP or hospital visits) from 9 months before the study begins through to the end of the study. Please note that HbA1c tests are a part of regular diabetes care and so you may be requested by your doctor to have these tests done while taking part in the study and it is important that you continue to do this as your doctor recommends. Phone calls can be at a time that suits you. At the end of the study you will receive a $20 voucher as reimbursement for your time taking part in the study. Who can take part in this study? To take part in the study you must:

- Be aged 16 years or older - Have type 1 or type 2 diabetes - Have an HbA1c >65mmol/ml in the last nine months - Have a mobile phone that can be used for this programme - Be able to provide informed consent - Be able to read English - Be available for the 9 month study duration

How long will the study take? This study is 9 months in duration. What are the risks and benefits of this study? We do not anticipate any risks with this study. However, taking part in this study will take some time. Your participation will help us to test this new way to deliver diabetes information and support, and may benefit people with diabetes in the future. It may also help you to self-manage your diabetes and prevent the long term complications associated with the disease. Will the information about me be kept confidential? The study files and all information that you provide will remain strictly confidential. No material that could personally identify you will be used in any reports on this study. The information will be kept securely by the National Institute for Health Innovation, The University of Auckland for 15 years. All computer records will be password protected. All future use of the information collected will be strictly controlled in accordance with the Privacy Act, 1994.

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During the study, ethics committee representatives, study personnel, members of the research team and possibly representatives of the study sponsor may check your records during the study. This will only be done to check the accuracy of information collected for the study and the information will remain confidential. When will the results be available? This study will take 18 months in total to conduct, so results will be available early 2017. You will be asked if you would like to be sent a copy of the overall results. Has the study received ethical approval? This study has received ethics approval from the Health and Disability Ethics Commission (ref: 14/STH/162). What are my legal rights? Your participation in this study is entirely voluntary (your choice). You do not have to take part. If you choose not to take part in this study you will not be affected in any way. You may withdraw from the study at any time, without having to give a reason. Your withdrawal from the study will not affect your future health care or your relationship with the University of Auckland. You are encouraged to ask questions at any time during the study. If you have any questions please contact the Study co-ordinator:

Rosie Dobson

National Institute for Health Innovation University of Auckland, Private Bag 92019

Ph: 64 9 373 7599 ext. 84766 [email protected]

Research Team: Dr Robyn Whittaker (Principal Investigator) Mr Tim Wood (Co-investigator) A/P Ralph Maddison (Co-investigator) Ms Rosie Dobson (Co-investigator and Study coordinator) Dr Matt Shepherd (Co-investigator) Dr Rick Cutfield (Co-investigator) Dr Catherine McNamara (Co-investigator) Dr Rinki Murphy (Co-investigator) Dr Manish Khanolkar (Co-investigator) Dr Yannan Jiang (Co-investigator)

If you have any questions or concerns regarding your rights as a participant in this study you may wish to contact an independent health and disability advocate:

Free phone: 0800 555 050 Free fax: 0800 2 SUPPORT (0800 2787 7678) Email: [email protected]

Thank you for taking time to read about this study.

Please keep this sheet for your information.

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Confidential: For Review OnlyAssessed for eligibility (n=793)

Excluded (n=427)• Not meeting inclusion criteria (n=79)

• Declined to participate (n=192)

• Unable to be contacted (n=118)

• Other reasons (n=38)

Total analysed (n= 177)

• Excluded from analysis (n=6)

Lost to follow-up (n=5)• Unable to contact (n=4)

• Deceased (n=1)

Discontinued allocated treatment (n=3)• Perceived intervention not useful (n=2)

• Health deteriorated (unrelated) (n=1)

Allocated to SMS4BG (n=183)• Received allocated treatment (n=183)

Lost to follow-up (n= 2)• Withdrew participation from study (n=1)

• Unable to contact (n=1)

Discontinued allocated treatment (n=0)

Allocated to standard care alone (n=183)• Received allocated treatment (n=183)

Total analysed (n=177)

• Excluded from analysis (n=6)

Allocation

Analysis

Follow-Up

Enrollment

Randomized (n=366)

Figure 1: Trial registration flow chart

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1

Cover pager

Effectiveness of text message-based diabetes self-management support programme (SMS4BG): A randomised controlled trial

Rosie Dobson, Robyn Whittaker, Yannan Jiang, Ralph Maddison, Matthew Shepherd, Catherine McNamara, Richard Cutfield, Manish Khanolkar, Rinki Murphy.

Authors' names, positions, and affiliations:

Rosie Dobson, Research Fellow, National Institute for Health Innovation, School of Population Health, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.

Robyn Whittaker, Public Health Physician, National Institute for Health Innovation, School of Population Health, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.

Yannan Jiang, Senior Research Fellow, National Institute for Health Innovation, School of Population Health, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.

Ralph Maddison, Professor, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hwy, Burwood VIC 3125, Australia.

Matthew Shepherd, Senior Lecturer, School of Counselling, Human Services and Social Work, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand

Catherine McNamara, Endocrinologist, Diabetes Service, North Shore Hospital, Private Bag 93 503, Takapuna, Auckland 0740, New Zealand

Richard Cutfield, Endocrinologist, Diabetes Service, North Shore Hospital, Private Bag 93 503, Takapuna, Auckland 0740, New Zealand

Manish Khanolkar, Endocrinologist, Auckland Diabetes Centre, Greenlane Clinical Centre, Private Bag 92189, Auckland 1142, New Zealand

Rinki Murphy, Associate Professor, School of Medicine, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand

*Corresponding author's contact information: Rosie Dobson National Institute for Health Innovation, School of Population Health, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand. +649 3737599 ext. 84766 (phone) +6421 767437 (mobile) [email protected] Twitter: @rosiedobson2 Word count: Abstract (272 words), Main body (3234 words) Keywords: mHealth; diabetes mellitus; text message; mobile phone; SMS; self-management

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2

Abstract Objective: To determine the effectiveness of a theoretically based and individually tailored text message diabetes self-management support intervention (SMS4BG) in adults with poorly controlled diabetes. Design: A 9-month, two-arm, parallel, randomised controlled trial Setting: Primary and secondary health care services in New Zealand. Participants: 366 participants aged 16 years and over with poorly controlled type 1 or type 2 diabetes (HbA1c≥65mmol/mol/8%) were randomised between June 2015 and November 2016, 183 in the intervention group and 183 in the control group. Interventions: Patients in the intervention group received a tailored package of text messages for up to 9 months in addition to usual care. Text messages provided information, support, motivation, and reminders related to diabetes self-management and lifestyle behaviours. Patients in the control group received usual care. Messages were delivered by a specifically designed automated content management system. Main outcome measures: The primary outcome measure was change in glycaemic control (HbA1c) from baseline to 9 months. Secondary outcomes included change in HbA1c at 3 and 6 months, self-efficacy, diabetes self-care behaviours, diabetes distress, perceptions and beliefs about diabetes, health-related quality of life, perceived support for diabetes management, and intervention engagement and satisfaction at 9 months. Regression models have adjusted for baseline outcome, health district category, diabetes type and ethnicity. Results: The reduction in HbA1c at 9 month was significantly greater in the intervention group (mean (standard deviation), -8.85(14.84)mmol/mol) compared with the control group (-3.96(17.02)mmol/mol), with an adjusted mean difference of -4.23mmol/mol (95%CI [-7.30 to -1.15], p=0.01). Statistically significant improvements were also seen at 9 months with intervention in foot care behaviour (adjusted mean difference 0.85, 95%CI [0.40 to 1.29], p<0.001), overall diabetes support (adjusted mean difference 0.26, 95%CI [0.03 to 0.50], p=0.03), health status on the EQ-5D VAS (adjusted mean difference 4.38, 95%CI [0.44 to 8.33], p=0.03), and perceptions of illness identity (adjusted mean difference -0.54, 95%CI [-1.04 to -0.03], p=0.04). No significant differences were observed for all other secondary outcomes. High levels of satisfaction with SMS4BG were found with participants reporting it to be useful (95%, 161/169), culturally appropriate (97%, 164/169), and would recommend the programme to other people with diabetes (97%, 164/169). Conclusions: This study found that a tailored text-message based self-management support programme was effective at improving HbA1c in adults with poorly controlled diabetes providing support for the implementation of SMS4BG to supplement current practice. Trial registration: Australian New Zealand Clinical Trials Registry Study ID number: ACTRN12614001232628 Link: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367369 Date of registration: 25 November 2014 The Universal Trial Number (UTN): U1111-1162-7072

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3

Background

The growing prevalence of diabetes is considered to be one of the biggest global health issues.1 People of ethnic minority, including Pacific and Māori (New Zealand indigenous population), are particularly vulnerable to the development of diabetes, experience poorer control, and increased rates of complications.2-6 In New Zealand it has been found that 29% of patients with diabetes have HbA1c levels indicative of poor control (≥65mmol/mol/8%) putting them at risk for the development of debilitating and costly complications.7 Diabetes complications can be prevented or delayed with good blood glucose control, which is not only advantageous for a person’s quality of life but will substantially decrease healthcare costs associated with treating or managing the complications.8-12

The flexibility of mobile phones and their adoption into everyday life mean they are an ideal tool in supporting people with diabetes whose condition requires constant management. Mobile phones, which have been used effectively to support diabetes management,13-16 offer an ideal avenue for providing care at the patient’s desired intensity. Additionally, they have potential to provide effective methods of support to patients in rural and remote locations where access to healthcare providers can be limited.17-18 Although there is growing support for the use of mobile health (mHealth) in diabetes, there is increasing evidence of a digital divide with lower use of some technologies in specific population groups,19,20, including those that have low health literacy,21 low income,22-24 and members of ethnic minorities.25,26 Contributing factors include low technology literacy, mismatch between individual needs and the available tools, lack of local information, cost, literacy and language barriers, and lack of cultural appropriateness.27 For mHealth tools to be used to address the issue of poor diabetes control they need to be designed to the needs and preferences of those that need greatest support by considering these factors.

The SMS4BG (Self-Management Support for Blood Glucose) intervention was developed to address the need for innovative solutions to support self-management in adults with poorly controlled diabetes.28 The individually tailored intervention provides information and support designed to motivate a person to engage in the behaviours required to manage their diabetes effectively for long term health improvement. The development of SMS4BG followed the mHealth Development and Evaluation Framework29 including extensive formative work and end-user engagement to ensure it met the needs of the population it was designed to reach, is evidence based, and theoretically grounded. A previous pilot study found SMS4BG to be acceptable and perceived as useful.28 This study aimed to determine the effectiveness of the mHealth diabetes self-management support programme - SMS4BG in adults with poorly controlled type 1 or type 2 diabetes, in addition to their usual diabetes care.

Methods

Study Design

A 9-month, two-arm, parallel, randomised controlled trial was conducted in adults with poorly controlled diabetes between June 2015 and August 2017. The study received ethical approval from the Health and Disability Ethics Committee (14/STH/162), and the protocol was published30 and registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614001232628). Trial development and reporting was guided by the CONSORT31 and CONSORT EHEALTH32 statements.

Participants

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4

Participants were referred to the study by healthcare professionals at their primary and secondary care centres across New Zealand. Additionally, participants could self-refer to the study. Eligible participants were English speaking adults aged 16 years and over with poorly controlled type 1 or 2 diabetes (defined as an HbA1c ≥65mmol/mol in the preceding 9 months). The initial protocol required an HbA1c above the cut-off within the last 3 months but this was extended to 9 months to ensure greater reach across those not having as regular tests following feedback from patients and clinicians. Participants required access to a mobile phone and needed to be available for the 9 month study duration.

Patient involvement

Patients were involved in all stages of the study, including the initial conceptualisation and formative work leading to the development of SMS4BG (for more information please see the development paper28). Patient feedback informed the intervention modality, purpose and structure, and patients reviewed intervention content before it was finalised. Patient feedback on the acceptability of SMS4BG through the pilot study28 led to improvements to the intervention including additional modules, the option for feedback graphs to be posted, additional tailoring variables, and a longer duration of intervention. Patient feedback also informed the design of this trial, specifically its duration, the inclusion criteria, and recruitment methods. Additionally, patients contributed to workshops of key stakeholders held to discuss interpretation, dissemination of the findings, and potential implementation.

We have thanked all participants for their involvement and they will be given access to all published results when these are made publically available.

Randomisation and blinding

Eligible participants were randomised to either intervention or control group in a 1:1 ratio. Randomisation was stratified by health district category (high urban or high rural/remote), diabetes type (1 or 2), and ethnicity (Māori & Pacific, or non-Māori/non-Pacific). The randomisation sequence was generated by computer programme using variable block sizes of 2 or 4, and overseen by the study statistician. Following participant consent and completion of the baseline interview, the Research Assistant (RA) then randomised the participant to intervention or control, using the REDCapTM randomisation module. The REDCapTM randomisation module ensured treatment allocation was concealed until the point of randomisation. Due to the nature of the intervention, participants were aware of their treatment allocation. RAs conducting the phone interviews were also aware of the treatment allocation. However, the objective primary outcome was measured by blinded assessors throughout the study period.

Procedures

Participants referred to the study by clinicians or who self-referred were contacted by an RA via phone to discuss the study and confirm eligibility. All eligible participants completed informed consent followed by baseline assessment over the phone with an RA prior to randomisation. All participants continued with their usual diabetes care including all medical visits, tests, and diabetes support programmes throughout the study. In addition, the intervention group received SMS4BG. Control participants received usual care only. All participants completed a follow up phone interview at 9 months (±3 weeks) post-randomisation. HbA1c blood tests (baseline, 3, 6 and 9 months) were undertaken through standard care and results obtained through medical records.

Intervention

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SMS4BG is an automated self-management support programme delivered by SMS to motivate and support a person to engage in the behaviours needed for successful diabetes management. The programme was tailored by the needs and goals of the individual, and demographic factors. As well as core motivational and support messages (in Māori, Pacific or non-Māori/Pacific cultural versions), participants could opt to receive additional modules including; insulin module, young adult module, smoking cessation module, lifestyle behaviour modules (exercise, healthy eating or stress/mood management), and foot care module (further module details can be seen in Table 1 in the Supplement).

Participants could choose to receive blood glucose monitoring reminders which they could reply to by sending in their result by text message. They could then view their results graphically over time on a password protected website. If at baseline they were identified as not having access to the internet they were mailed their graphs once a month. All messages were delivered in English although the Māori version included key words in Te Reo Māori and the Pacific version key words in either Samoan or Tongan dependent on ethnicity. Examples of SMS4BG messages can be seen in the box. Participants were able to select the timing of messages and reminders, and identify the names of their support people and motivations for incorporation into the messages. The duration of the programme was also tailored to individual preferences; at 3 and 6-months, participants received a message asking if they would like to continue the programme for an additional 3-months and had the opportunity to re-select their modules receiving up to a maximum 9-months of messages. Participants could stop their messages by texting the word ‘STOP’ or put them on hold by texting ‘HOLIDAY’.

Box

Examples of SMS4BG text messages

Core message – Maori version


Young adult message


Smoking cessation message


Healthy eating message


Stress and mood management message


Blood glucose monitoring reminder

SMS4BG: [hi] [name]. Just a reminder it is time to check your blood glucose.

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Reply with the result

Foot care message

SMS4BG: Looking after your feet will help to prevent issues in the future. Check your feet daily & contact your doctor, nurse or podiatrist if there are changes

The message delivery was managed by our Content Management System with messages sent and received through a gateway company to allow for participants to be registered with any mobile network. Sending and receiving messages was free for participants. The system maintained logs of all outgoing and incoming messages. Further details of the intervention can be seen in the published pilot study,28 and protocol.30

Outcome measures

Primary outcome

The primary outcome measure was change in glycaemic control from baseline to 9 months follow up, measured as HbA1c (in mmol/mol, or equivalently in %).

Secondary outcomes

Secondary outcome measures included change in HbA1c at 3 and 6-months follow up, and the following outcomes at 9 months: self-efficacy for diabetes management (Stanford Self-efficacy for Diabetes scale (SEDM)33), diabetes self-care behaviours including diet (general and specific), exercise, blood glucose monitoring, and foot care (Summary of Diabetes Self-Care Activities (SDSCA) measure34) the presence of diabetes-related distress (2-item Diabetes Distress Scale (DDS2)35), perceptions and beliefs about diabetes (Brief Illness Perception Questionnaire (BIPQ)36), health related quality of life (EQ-5D (index score and visual analogue scale (VAS))37), and perceived social support for diabetes management (measured using a 4 item measure developed for this study assessing overall support, appraisal support, emotional support and advice/information support; see protocol paper for measure details30). In addition, cost-effectiveness was assessed as well as healthcare utilisation during the study period compared to the 9-months prior to randomisation (presented separately). Patient engagement and satisfaction with the intervention was measured using semi-structured interviews and data from the content management system. The secondary outcomes health related quality of life and perceived social support were not included in the initial trial registration but added prior to commencing the trial.

Statistical analysis

As published in the protocol, a sample size of 500 participants (250 per arm) was estimated to provide 90% power at 5% significance level to detect a clinically meaningful group difference of 0.5% (5.5mmol/mol) in HbA1c at 9 months, assuming a standard deviation of 1.7% (18.6mmol/mol). Despite extensive efforts, recruitment for the study was slower than expected, and with the limited overall study period available, a post-hoc power calculation was conducted in September 2016. A revised sample size of 366 participants (183 per arm) was targeted, which would provide 80% power to detect the same effect size under the same assumptions.

Statistical analyses were performed using SAS version 9.4 (SAS Institute Inc. Cary NC). All statistical tests were two-sided at a 5% significance level. Analyses were performed on the principle of intention to treat, including all randomised participants who provided at least one valid measure on the primary outcome post randomisation. Demographics and baseline

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characteristics of all participants were first summarised by treatment group using descriptive statistics. No formal statistical tests were conducted at baseline, as any baseline imbalance observed between two groups could have occurred by chance with randomisation. The primary and secondary outcomes were summarised using descriptive statistics at each scheduled visit. Random effects mixed model was used to evaluate the effect of intervention on HbA1c at 3, 6, and 9-months follow up, adjusting for baseline HbA1c and stratification factors and accounting for repeated measures over time. Model-adjusted mean differences in HbA1c between two groups were estimated at each visit, by including an interaction term between treatment and month. Missing data on the primary outcome were taken into account in modelling based on the missing at random assumption. Both 95% confidence interval (CI) and p-value were reported. The size of treatment effects were also compared between important subgroups considered in stratification, including type of diabetes (type 1 and 2), ethnicity (Māori/Pacific and non-Māori/non-Pacific), and region (urban and rural). For other secondary outcomes measured at 9 months, generalised linear regression models were used with same covariate adjustment using a link function appropriate to the distribution of outcomes. Model-adjusted estimates on the treatment difference between two groups at 9 months were reported, together with 95% confidence intervals and p-values. No imputation was considered on secondary outcomes.

Results

A total of 793 individuals were referred to the study and assessed for eligibility between June 2015 and November 2016. Of these, 366 were randomised to the intervention (n=183) and control (n=183) groups (Figure 1). The final 9-month follow up assessments were completed in August 2017 with the loss to follow-up (no follow up data on any outcome) rate low in both groups (overall 7/366=2%). A total of 12 participants (six per group) were excluded from the primary outcome analysis due to no follow up HbA1c results post randomisation. The baseline characteristics of participants are presented in Table 1. There were no adverse events from the study or protocol deviations.

Figure 1: Trial registration flow chart

Primary Outcome

The main treatment effect on the primary outcome is presented in Table 2. The reduction in HbA1c from baseline to 9 month follow-up was statistically significantly greater in the intervention group compared with the control group (mean(standard deviation), -8.85(14.84) vs. -3.96(17.02)mmol/mol, adjusted mean difference -4.23, 95%CI [-7.30 to -1.15], p=0.007). The adjusted mean difference on change in HbA1c at 3 and 6 months were -4.76 (95%CI [-8.10 to -1.43], p=0.005) and -2.36 (95%CI [-5.75 to 1.04], p=0.17), respectively (Table 2).

A decrease in HbA1c from baseline to 9 month follow-up was observed in 75% of intervention participants compared to 61% of control participants (Chi-square test, p=0.01). At 9 months 28% of intervention and 18% of control participants HbA1c levels dropped below 65mmol/mol (p=0.04).

There was no statistically significant interaction between treatment and any of the pre-specified subgroups: type 1 vs. type 2 (p=0.82), non-Māori/non-Pacific vs. Māori/Pacific (p=0.60), high urban vs. high rural/remote (p=0.38). The adjusted mean differences on change in HbA1c from baseline to 9 months for type 1 and type 2 diabetes patients were -5.75 (95%CI [-10.08 to -1.43], p=0.009) and -3.64mmol/mol (95%CI [-7.72 to 0.44], p=0.08), respectively. The adjusted mean differences for non-Māori/non-Pacific and Māori/Pacific people were -4.97 (95%CI [-8.51 to -1.43], p=0.006) and -3.21mmol/mol (95%CI [-9.11 to

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2.70], p=0.28), respectively. The adjusted mean differences for those living in high urban and high rural/remote areas were -4.54 (95%CI [-8.40 to -0.68], p=0.02) and -3.94mmol/mol (95%CI [-9.00 to 1.12], p=0.13), respectively (Table 3).

Secondary Outcomes

The main effect of the intervention on secondary outcomes are presented in Table 4. No statistically significant differences were observed between groups for self-efficacy (SEDM). A statistically significant improvement in foot care behaviour was seen in the intervention group compared with the control group (adjusted mean difference 0.85, 95%CI [0.40 to 1.29], p<0.001) but no statistically significant group differences were observed for diet (general or specific), exercise, blood glucose testing and smoking behaviours (SDSCA). No statistically significant group differences were observed for diabetes distress (DDS2).

In relation to perceptions and beliefs about diabetes, a statistically significant reduction in illness identity (how much they experience diabetes related symptoms) on the BIPQ was observed in favour of the intervention (adjusted mean difference -0.54, 95%CI [-1.04 to -0.03], p=0.04) but no statistically significant group differences were observed for perceptions of consequences, timeline, control, concern, emotions, and illness comprehensibility.

A statistically significant improvement in health status on the EQ-5D VAS was observed in favour of the intervention (adjusted mean difference 4.38, 95%CI [0.44 to 8.33], p=0.03) but no statistically significant differences were observed between groups for the quality of life index score.

Finally the measure of perceived support for diabetes management showed that there was a statistically significant improvement between the groups in how supported the participants felt in relation to their diabetes management overall (adjusted mean difference 0.26, 95% CI [0.03 to 0.50], p=0.03) but there was no statistically significant group differences were observed on the measures of appraisal, emotional, and informational support.

Participant satisfaction and acceptability

Among the intervention participants, 169 (92%) completed questions at follow up about satisfaction and acceptability of the intervention (Table 5). Participants reported high levels of satisfaction with SMS4BG and all but two participants (167; 99%) thought that text messaging was a good way to deliver this type of support. There were 10 participants who reported technical issues while receiving the intervention, most commonly issues replying to the messages (n=4), issues accessing graphs(n=2), and mobile reception issues (n=2).

Participant engagement

Due to individual tailoring, intervention participants received varying numbers of messages. Half of the participants received messages for 3-months, an additional 18% chose to continue the messages for 6-months and the remaining 32% chose to continue the messages to the maximum 9-months. Only three participants chose to stop their messages early. A total number of 76,523 messages were sent by the system to participants (median per participant:242;IQR:122-511;range:14-2050), and a total of 16,251 blood glucose results were sent into the system by participants receiving the reminders (median per participant:68;IQR:1-169;range:0-917).

Discussion

This study found that a tailored theoretically based SMS diabetes self-management support programme led to statistically significant improvements in glycaemic control. Statistically

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significant improvements in foot care behaviour and ratings of diabetes support were also seen in intervention participants compared with control participants. There was a high level of acceptability of the intervention with the overwhelming majority finding the intervention useful and would recommend it to others.

It is well documented that any decrease in HbA1c is likely to be associated with a decrease in the risk of diabetic complications.38 Reductions of HbA1c are much more clinically important at higher levels given the association between vascular complications and HbA1c is nonlinear and there is much less impact of similar reductions at lower HbA1c levels.38,45,46

In a less ethnically diverse population of people with type 2 diabetes at levels of above 6.5% (53mmol/mol) a decrease in HbA1c of 1%(11mmol/mol) has been found to result in declines in microvascular complications of 37%, myocardial infarction of 14%, and risk of death by 21%.38 With over 75% of intervention participants experiencing a decrease in HbA1c at 9 months, with a mean reduction in HbA1c of 9.6mmol/mol(0.9%) from baseline, and a statistically significant group difference of 4.2mmol/mol(0.4%) in favour of the intervention, the results seen in this study have potential to be clinically relevant in reducing the risk of vascular complications and death.

Although we chose a 5.5mmol/mol (0.5%) reduction in HbA1c as a clinically significant level for our initial power calculation, we consider the average reduction of 4.2mmol/mol (0.4%) in HbA1c to still be clinically relevant in practice particularly among those who have a high HbA1c such as the participants with ‘poor control’ in this study. The unadjusted group difference on change in HbA1c from baseline was -5.89, -3.05 and -5.24mmol/mol at 3, 6 and 9 months respectively, and the main analysis with adjustment for baseline value and stratification factors, showed a smaller treatment effect although both results were statistically significant at 3 and 9 months. Similar results were found across major subgroups of interest despite the fact that these analyses were not specifically powered. These consistent findings led us to believe that the intervention has showed promising effects on treating people with poorly controlled diabetes and warrants further investigation.

This study contributes to the evidence around the use of SMS to support diabetes management.13-15 The improvements in HbA1c seen in this study are similar to those reported in meta-analyses of SMS interventions in diabetes not limited to those with poor control.14,16,39 Unlike previous studies that typically study a particular population defined by diabetes type, age, or treatment, the current study provided an intervention for all adults with either type 1 or type 2 diabetes under any treatment regimen making the potential reach greater and enhancing generalisability. The only limit on the population was the requirement that participants had poor diabetes control. This is particularly important given associated costs and debilitating complications of poorly controlled diabetes. Although few trials to date have examined the effectiveness of mHealth interventions in this population,40 this study provides evidence to support the use of this modality to provide diabetes education and support to those with poor control.

The control group also experienced a decrease in HbA1c from baseline to the 9 month follow up and experienced improvements in secondary outcomes, which could indicate trial effects. Previous research has shown that recruitment to a clinical trial alone can result in improvements in HbA1c,41 but it is not expected that these would be sustainable past the initial few months without intervention.

Strengths

Strengths of the current study included its sample size, diverse population, very low loss to follow up, pragmatic design, absence of protocol violations, and objectively measured primary outcome. Although the initial sample size target was not reached the final sample of 366 is larger than previous randomised controlled trials in this area. This study contributes

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valuable evidence to the literature on the use of text messages in diabetes particularly for those with poor control. Considering poorer outcomes are experienced by ethnic minority groups, a strength of this study was its high proportion of participants representing these groups.

Strengths of the intervention are that it was theoretically based, the information reinforced messages from standard care, and it was system initiated, personally tailored, and utilised simple technology. These strengths result in high relevance to diverse individuals increasing its reach and acceptability. Unlike SMS4BG, previous diabetes SMS programmes have largely focused on specific groups e.g. type 1, limiting their generalisability. Furthermore, the SMS4BG intervention was tailored and personalised to the individual. Although this results in a more complex intervention in relation to its delivery, it appears that this is a worthwhile endeavour with high satisfaction and the majority of participants happy with their message dosage.

Limitations

The biggest limitation of this study was the difficulty with recruitment which resulted in a sample size smaller than initially planned. One reason for the low recruitment was the required time on the part of the clinician to identify and refer patients to the study, something that wasn't always available. Furthermore, many referred patients did not meet the HbA1c inclusion criteria but clinicians had referred as they felt they would benefit from the programme. This highlights the difference between research and implementation where strict criteria can be relaxed. Alternative methods of recruitment could be explored such as through lab test facilities to ensure access to the intervention regardless of clinician availability.

Due to time restrictions longer term follow-up of participants was not feasible within the current study, although it is hoped that a 2-year follow up of the participants in this study may be possible. The statistically significant group difference seen at 3 months, dropping slightly at 6 months, but reaching significance again at 9 months, could be an indication of sustained change. Another limitation of the study design was that secondary outcome assessors were not blinded to treatment allocation which could have introduced bias in follow-up data collection of secondary variables.

SMS4BG was delivered in the English language (with the exception of some Māori, Samoan, and Tongan words). With high rates of diabetes in ethnic minority groups, delivery of this type of intervention in languages native to these groups may result in greater benefit. It is likely that some people were not referred to the study, or were unable to take part, due to the criteria that they must be able to read English. Translation of SMS health programmes into other languages such as Te Reo,42 and so further research needs to look at whether this would be of benefit in SMS4BG.

Implications

This study shows the potential of SMS4BG to provide a low-cost, scalable solution for increasing the reach of diabetes self-management support. It showed that a text messaging programme can increase a patient’s feelings of support without the need for personal contact from a healthcare professional. Half of the intervention group reported sharing the messages with others. Traditional diabetes self-management education is delivered to individual patients but there is benefit of support people being involved.43 This is particularly pertinent to ethnic groups such as Māori whose family play an important role in supporting diabetes self-management.44

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With technology advancing rapidly there is a call for mHealth to move towards more complex technology. However, this study has shown that text messaging – available on any mobile phone - although simple, is still effective for improving glycaemic control. Equally there were very few technical issues experienced in this study, likely contributing to the high satisfaction with the intervention. The individual tailoring of the intervention, and ability for participants to choose varying components and dosages, means that questions remain around the ideal duration for implementation as well as the components most important for effectiveness. Further research is needed to understand the components of this intervention that are most effective and the ideal intervention dosage to further refine this intervention and inform the development of future interventions. With participants highly satisfied with the intervention and largely happy with their intervention dosage, but great variable in the modules, durations and dosages, it may be that SMS4BG should remain individually tailored in this way resulting in a more complex intervention for delivery until further investigation on this can be made

Conclusions

This study found that a tailored and automated SMS self-management support programme was effective at improving glycaemic control in adults with poorly controlled diabetes. Although the full duration of these effects is yet to be determined, exploration of SMS4BG to supplement current practice is warranted.

What is already known on this topic:

Effective diabetes self-management support is vital to address the increase in costly and debilitating long-term complications associated with poor diabetes control.

Text messages (SMS) are an ideal tool for the delivery of self-management support given the ubiquity of mobile phones, and the ability of SMS to reach people in their everyday lives where self-management of diabetes is crucial.

There is increasing evidence supporting the use of SMS for the delivery of diabetes self-management support but the effectiveness in those with poor control of the condition, a group arguably most in need of intervention, is less clear.

What this study adds:

This study provides evidence that text messaging is an effective and well received modality for the delivery of self-management support to people with poorly controlled diabetes.

SMS interventions have the potential to make culturally appropriate and personalised self-management support accessible to nearly all people with diabetes regardless of location.

Acknowledgements

We would like to thank the participants who took part in this study as well as the staff at the primary care practices and diabetes clinics across New Zealand who referred their patients to the study. We would also like to thank the National Institute for Health Innovation’s IT team for their work on the text message delivery system, and all those involved in the study design and set up. We would like to thank Coral Skipper, Louise Elia, Erana Poulsen, and Hamish Johnstone (Māori Advisory Group members), Aumea Herman (Pacific Advisor), Joanna Naylor, Michelle Garrett (Content Development Advisors), Richard Edlin (Health Economist), Mahalah Ensor (Assistance with recruitment), Hannah Bartley, Rachel Sullivan, Anne Duncan and Gillian Lockhart (Research Assistants), Michelle Jenkins and John Faatui

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(Data Management Support), Karen Carter and Angela Wadham (Project Management Support).

Competing interests

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: We acknowledge funding from Waitemata District Health Board for the development of SMS4BG. The randomised controlled trial was funded by the Health Research Council of New Zealand in partnership with Waitemata District Health Board and Auckland District Health Board (through the Research Partnerships for New Zealand Health Delivery initiative), and the New Zealand Ministry of Health. The funders were not involved in any way in the preparation of the manuscript or analysis of the study results; we declare no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Author contributions

RW obtained funding for this trial. All co-authors had input into the study protocol. RD, RW, RMu, and MS contributed to the development of the intervention content. RD managed the day-to-day running of the trial and delivery of the intervention. RD and RW collected the data. YJ and RD did the data analyses. All co-authors were involved in the interpretation of the results. This Article was written by RD with input from all co-authors. All authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. All authors approved the final version of this manuscript. RD is guarantor for this Article.

Funding

The development of SMS4BG was funded by Waitemata District Health Board. The randomised controlled trial was funded by the Health Research Council of New Zealand in partnership with Waitemata District Health Board and Auckland District Health Board (through the Research Partnerships for New Zealand Health Delivery initiative), and the New Zealand Ministry of Health. The funders were not involved in any way in the preparation of the manuscript or analysis of the study results. No payment has been received for writing this publication.

Ethical approval:

The study received ethical approval from the New Zealand Health and Disability Ethics Committee (14/STH/162). All participants provided informed consent to take part in the trial.

Transparency:

The lead author (manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained.

Copyright

The Corresponding Author has the right to grant on behalf of all authors and does grant on behalf of all authors, a worldwide licence to the Publishers and its licensees in perpetuity, in all forms, formats and media (whether known now or created in the future), to i) publish,

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reproduce, distribute, display and store the Contribution, ii) translate the Contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or, abstracts of the Contribution, iii) create any other derivative work(s) based on the Contribution, iv) to exploit all subsidiary rights in the Contribution, v) the inclusion of electronic links from the Contribution to third party material where-ever it may be located; and, vi) licence any third party to do any or all of the above.

Data sharing:

The research team will consider reasonable requests for sharing of de-identified patient level data. Requests should be made to the corresponding author. Consent for data sharing was not obtained but the presented data are anonymised and risk of identification is low.

Study protocol: Dobson R, Whittaker, R. Jiang, Y. Shepherd, M. Maddison, R. Carter, K. Cutfield, R. McNamara, C. Khanolkar, M. Murphy, R. Text message-based diabetes self-management support (SMS4BG): Study protocol for a randomized controlled trial. Trials 2016 17:179.

doi.org/10.1186/s13063-016-1305-5 Link: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1305-5

Original protocol available from corresponding author on request.

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Table 1: Baseline characteristics of participants. Values are numbers (percentages) unless

stated otherwise

Characteristic Intervention group (N=183)

Control group (N=183)

Gender: Male 92 (50) 97 (53)

Ethnicity

Māori 37 (20) 46 (25)

Pacific 29 (16) 20 (11)

Asian 8 (4) 12 (7)

New Zealand European 93 (51) 88 (48)

Other 16 (9) 17 (9)

Ethnicity category

Māori/Pacific 66 (36) 66 (36)

non-Māori/non-Pacific 117 (64) 117 (64)

Diabetes type

Type 1 65 (36) 64 (35)

Type 2 118 (65) 119 (65)

Location

High urban 125 (68) 117 (64)

High rural/remote 58 (32) 66 (36)

Smoking status

Smoker 29 (16) 35 (19)

Non-smoker 154 (84) 148 (81)

Treatment: Insulin 142 (78) 145 (79)

Referral source

Primary care 72 (39) 77 (42)

Secondary care 106 (58) 105 (57)

Self-referred 5 (3) 1 (1)

Age grouping

16-24 years 25 (14) 21 (12)

25-49 years 66 (36) 65 (36)

50-64 years 73 (40) 77 (42)

≥65 years 19 (10) 20 (11)

Age (years), mean (SD) 47 (15) 47 (15)

Time since diagnosis (years), mean (SD) 13 (11) 12 (9) SD – Standard deviation

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Confidential: For Review Only19

Table 2: Treatment effect on the primary outcome (HbA1c (mmol/mol)). Values are mean (SD) unless stated otherwise.

Intervention

(n=177) Control (n=177)

Un-adjusted Mean difference (95% CI)

1 P value for difference

Adjusted Mean difference (95% CI)


Baseline 86.37 (17.83) 83.30 (14.80)

Change from baseline at 3 months

-8.70 (14.61) -2.7 (15.1) -5.89 (-9.41 to -2.36) 0.001 -4.76 (-8.10 to -1.43) 0.005


-7.16 (14.14) -4.93 (13.97) -3.05 (-6.63 to 0.54) 0.10 -2.36 (-5.75 to 1.04) 0.17


-8.85 (14.84) -3.96 (17.02) -5.24 (-8.52 to -1.97) 0.002 -4.23 (-7.30 to -1.15) 0.007

1 Random effects mixed model without and with adjustment for baseline outcome, diabetes type, ethnicity and region. Both treatment group and visit were included in the

model with their interaction term. A random subject effect was added to account for repeated measures on same participant. SD – standard deviation. CI – confidence interval.

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Table 3: Treatment effect on the primary outcome (HbA1c (mmol/mol)), by key subgroups. Values are mean (SD) unless stated otherwise.

Intervention (n=177)

Control (n=177)


1

P value for difference

Diabetes type

Type 1 Baseline 87.55 (18.95) 82.64 (12.34)

Change from baseline at 3 months -8.84 (11.15) -1.28 (12.33) -7.67 (-12.45 to -2.88) 0.002

Change from baseline at 6 months -3.76 (12.41) -3.02 (9.66) -1.05 (-5.92 to 3.82) 0.67


Type 2 Baseline 85.73 (17.24) 83.65 (15.98)




Ethnicity

Māori/ Pacific

Baseline 91.08 (19.95) 85.17 (13.56)




non-Māori/ non-Pacific

Baseline 83.73 (16.02) 82.24 (15.38)




Location

High rural/ remote

Baseline 85.21 (18.91) 83.12 (17.13)


Change from baseline at 6 months -7.52 (13.88) -6.38 (15.77) 0.14 (-5.53 to 5.80) 0.96


High urban Baseline 86.92 (17.37) 83.39 (13.35)



Change from baseline at 9 months -8.40 (14.07) -3.18 (16.95) -4.54 (-8.40 to -0.68) 0.02 1 Random effects mixed model has adjusted for baseline outcome, diabetes type, ethnicity and region. Both treatment group and visit were included in the model with their

interaction term. A random subject effect was added to account for repeated measures on same participant. SD – standard deviation. CI – confidence interval.

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Table 4: Treatment effect on secondary outcomes. Values are mean (SD) unless stated otherwise.

Intervention (n=169)

Control (n=172)



Secondary outcome Baseline 9 months Baseline 9 months

Self-efficacy (SEDM) 6.94 (1.48) 7.55 (1.33) 6.93 (1.68) 7.44 (1.46) 0.11 (-0.13 to 0.36) 0.36

Diabetes self-care behaviours (SDSCA)

General diet 4.33 (1.98) 4.91 (1.78) 4.37 (2.06) 4.99 (1.79) -0.10 (-0.45 to 0.25) 0.58

Specific diet 3.84 (1.44) 4.25 (1.39) 3.89 (1.59) 4.19 (1.38) 0.09 (-0.18 to 0.36) 0.50

Exercise 3.11 (2.15) 3.45 (2.03) 3.27 (2.32) 3.48 (2.19) 0.06 (-0.35 to 0.48) 0.76

Blood glucose testing 4.38 (2.63) 4.85 (2.57) 4.24 (2.72) 4.85 (2.54) -0.13 (-0.58 to 0.33) 0.59

Foot care 1.93 (2.19) 2.75 (2.51) 1.97 (2.17) 1.92 (2.13) 0.85 (0.40 to 1.29) <0.001

Diabetes distress (DDS2) 3.37 (1.50) 3.03 (1.48) 3.44 (1.54) 3.26 (1.56) -0.18 (-0.45 to 0.10) 0.21

Perceptions and beliefs about diabetes (BIPQ)

Consequences 5.38 (2.72) 5.24 (2.76) 4.92 (2.79) 5.42 (2.78) -0.34 (-0.86 to 0.18) 0.20

Timeline 9.06 (1.72) 9.05 (1.99) 8.61 (2.37) 8.72 (2.18) 0.22 (-0.19 to 0.62) 0.29

Personal control 5.84 (2.23) 6.84 (2.10) 6.09 (2.39) 6.81 (2.10) 0.10 (-0.30 to 0.50) 0.62

Treatment control 8.15 (1.81) 8.62 (1.56) 8.08 (2.03) 8.45 (1.68) 0.15 (-0.18 to 0.49) 0.37

Identity 5.05 (2.74) 4.62 (2.70) 4.56 (2.78) 4.97 (2.60) -0.54 (-1.04 to -0.03) 0.04

Concern 7.23 (2.78) 6.55 (2.98) 6.99 (2.88) 6.47 (2.99) -0.04 (-0.57 to 0.50) 0.89

Emotions 5.36 (3.02) 4.74 (3.17) 4.70 (3.34) 4.90 (3.06) -0.37 (-0.97 to 0.23) 0.23

Illness comprehensibility

7.65 (2.14) 8.36 (1.60) 7.73 (2.15) 8.24 (1.78) 0.15 (-0.18 to 0.48) 0.38

Health related quality of life (EQ-5D)

Index 0.83 (0.17) 0.84 (0.17) 0.84 (0.18) 0.84 (0.17) 0.00 (-0.03 to 0.04) 0.81

Health status VAS 66.24 (19.02)

73.22 (19.88)

70.03 (19.87)

70.03 (19.51)

4.38 (0.44 to 8.33) 0.03

Perceived support for diabetes management

Overall support 4.75 (1.42) 5.14 (1.11) 4.89 (1.30) 4.94 (1.25) 0.26 (0.03 to 0.50) 0.03

Appraisal 5.13 (1.29) 5.30 (1.13) 5.20 (1.23) 5.21 (1.17) 0.11 (-0.13 to 0.35) 0.38

Emotional 5.14 (1.31) 5.30 (1.19) 5.20 (1.18) 5.20 (1.21) 0.11 (-0.13 to 0.35) 0.36

Advice/ information 5.39 (1.05) 5.57 (1.03) 5.33 (1.11) 5.54 (0.89) 0.01 (-0.18 to 0.20) 0.90 1

Linear regression model has adjusted for baseline outcome, diabetes type, ethnicity and region SEDM: Self efficacy for diabetes management; SDSCA: Summary of Diabetes Self-Care Activities; DDS2: Diabetes Distress Scale 2-item; BIPQ: Brief Illness Perceptions Questionnaire; QOL; Quality of life; VAS: Visual analogue scale; SD: Standard deviation; CI: Confidence interval.

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Table 5: Intervention satisfaction and acceptability results (n=169). Values are numbers (percentages).

Question Response yes

Was SMS4BG useful? 161 (95)

Were the messages culturally appropriate? 164 (97)

Were the messages age appropriate? 166 (98)

Would you recommend SMS4BG to others with diabetes? 164 (97)

Did you share the messages with any other people? 85 (50)

Did taking part in this programme help you learn about your diabetes? 120 (71)

Did taking part in this programme impact on how you manage your diabetes or help you change your behaviours?

140 (83)

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· 2018. 5. 21. · confidential: for review only effectiveness of text message-based diabetes...

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