16th Nordic Congress of General PracticeCopenhagen, May 14, 2009

Helle Terkildsen Maindal, RN, MPH, PhDDepartment of General Practice, Aarhus University, Denmark

Anglo-Danish-Dutch study of intensive treatment in people with screen detected diabetes in primary careDevelopment of

the “Ready to Act” intervention

Aims of this presentation

• The intervention developmental process• Knowledge of the target group

• Choice of theories

• Translation of evidence and theory

• Define a replicable intervention

• Choice of outcomes

What kind of intervention is needed?

• People with prediabetes and T2 diabetes diagnosed by screening in

general practice, recruited from the ADDITION-study *

• The screening-procedure was followed by early multi-factorial

behavioural and pharmacological interventions

• This intervention is one of the behavioural interventions and aims at

individual health promotion

*The Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-

Detected Diabetes in Primary Care

Yet another education programme?

Known

• Education combined with activation improves self-management and health outcomes (Renders, Norris, Glasgow)

• Social support enhances lifestyle adjustments (Van Dam, Norris)

• Support from nurse/case manager/multi-disciplinary teams improves outcome in patient education (Renders, Loveman)

Not known

• Special needs of a newly diagnosed screen-detected population (Adriaanse, Thoolen )

• Efficient intervention components (Norris, Gary)

Method: MRC, UK Framework for design and evaluation of the intervention

Campbell, M. et al. BMJ 2000;321:694-696

Pre-clinical phase

Aims Methods Data sources

Explore evidence of specific educational needs of a screen-detected population with dysglycaemia in primary care

Literature review

Exploring theory

Medline search : 35 articles found, 14 included

Health promotion and education theories

Empirical evidence

”Right at the beginning you

need somebody’s arms around you”

(Peel, 2004)

”Right at the beginning you

need somebody’s arms around you”

(Peel, 2004)

”No symptoms, no

problem?” (Adriaanse,

2003, Lawton, 2005)

”No symptoms, no

problem?” (Adriaanse,

2003, Lawton, 2005)

”I feel I lack of knowledge and

confidence” (Lawton, 2005)

”I feel I lack of knowledge and

confidence” (Lawton, 2005)

”My GP focus on the blood sugars - I focus on my

cooking”(Woodcock,2001)

”My GP focus on the blood sugars - I focus on my

cooking”(Woodcock,2001)

”It is a mild disease”

(Adriaanse, 2002)

”It is a mild disease”

(Adriaanse, 2002)

Theoretical phase (pre-clinical)

Action Learning theory (Tilbury 2005, Burke 2007)

Social Cognitive theory(Bandura 1997,2004)

Self-determination theory (Deci og Ryan 2000, 2002, 2005)

•Internal versus external motivation

•Perceived competence

•Social relatedness

•Self-regulatory motivation

•Knowledge and skills

•Social reflection

•Expectations and ambivalence

•Self-efficacy

•Collective self-efficacy

•Social support

Phase I: Intervention modelling

Aims Methods Data sources

To identify intervention

components

To define the

pedagogical activities

To identify collaborative

and training needs

Expert

meetings

Worksheet

testing

Physiotherapists, GPs, dieticians

and nurses with expertise in

dysglycaemia and health

promotion

12 persons with newly diagnosed

type 2 diabetes from a local

diabetes class

Theoretical constructs Self-regulatory motivation (ALT)

Knowledge and skills (ALT)

Social reflection (ALT)

Expectations/ambivalence (SCT)

Self-efficacy (SCT)

Collective self-efficacy (SCT)

Social support (SCT)

Internal motivation (SDT)

Perceived competence (SDT)

Social relatedness (SDT)

Translation of theory

Enhance motivationIndividual motivational interviews aim to clarify health beliefs, expectations, ambivalence and self-efficacy/perceived competence. Intrinsic motivation to individual actions is supported. Goal setting and action planning is introduced. Feed back is provided

Support Informed decision-makingGroup sessions on knowledge of health risks and health actions e.g. diet, exercise, action planning is provided by multidisciplinary teams, which means that diabetes/practice nurses, dietician, physiotherapist, and GPs work to tailor an intervention to meet the specific needs of a particular group.

Achieve Action experienceAction experiences were planned as part of each session and the participants were offered e.g. supervised aerobic exercise in safe environment, and skills training according to blood sugar measurements. During the group sessions the participants work with goal setting and action planning to prepare them for further actions after the intervention.

Support Social involvement The intervention is primarily group-based to support the exchange of experiences and to build up collective self-efficacy. The intervention was locally based to make local ressources visible (health professionals, peers, environments.

Table 1. The relationship between the text of the intervention letter and theoretical constructs

Components in the intervention

Action Competence

Individualinterview

IndividualinterviewGroup meetings

Health beliefs

Readiness to change

Outcome expectan-cies

Action plan

Feed back

Looking ahead

Social support

Informed decision-making

Motivation Informed decision-making

Action experience Social involvement

Phase II: Pilot test of intervention

Aims Methods Data sources

To identify final

sequences and

components

To evaluate the

feasibility of

delivering in primary

care

Observation

Video recording

Focus groups

Short questionnaire

Informal evaluation

Nurses (n=2) and participants (n=16)

Nurses (n=2) and dieticians (n=1)

Participants groups (n=16)

Participants groups (n=14)

Health care educators (n=7)

Evaluation after pilot tests

•Evaluation of the intervention process•Some participants called for more ”pressurising”•The participant-centred approach was reached•The number of group versus individual sesssions were sufficient

[“I am glad they [the educators] did not talk all the time; if they do, something is lost. No, the way we got involved kept me awake.”]

•Evaluation of the intervention outcome•Participants reported readiness for behaviour changes•Participants felt a positive influence on their health behaviour•Participants felt motivated by learning new skills

[“The bikes at the physiotherapist were so good, I got my arms and legs moving in a way I did not know I could.”]

Action Competence

Individualinterview

IndividualinterviewGroup meetings

Health beliefs

Readiness to change

Outcome expectan-cies

Action plan

Feed back

Looking ahead

Social support

Informed decision-making

Motivation Informed decision-making

Action experience

1

Cardio-vascular risk and dys-glycaemia:

Symptoms, signs, physiology, causes and treatment. Action planning.

2

Preventive actions:

Health behaviour and medical treatment.

The collabo-rativelapproach.

3

Actions related to diet:

Blood glucose, lipids, weight and well-being.

Change strategies.

Action planning.

4

Actions related to physical activity:

Physical exercise and blood glucose.

Change strategies.

Resources and barriers.

5

Actions related to diet:

Health beliefs.

Foods composi-tion and purchase.

6

Actions related to diet:

Skill training.

Eating patterns.

Everyday and occasional food.

7Actions related to physical activity:

Skill training.

Effects on risk, weight and blood glucose.

8

Attitude to risk and diagnosis:

Variations in feelings.

Action planning.

Support and local resources.

Nurse and GPNurse NurseNurse Dietician Dietician

Physio-therapist

Physio-therapistDietician Nurse

Social involvement

Choice of outcomes

• Initial outcomes (3 months)

• Autonomy support

• Perceived outcome

• Recommend the intervention to others

• Intermediary outcomes (1 year)

• Treatment motivation

• Perceived competence

• Long-term outcomes (1 year)

• Activation

• Dietary quality

• Physical activity

• Long-term outcomes (3 year)• HbA1c

• Lipids• Body Mass Index• Cardiovascular risk score

Conclusion

The MRC framework provided useful guidelines

• The Preclinical phase helped to identify intervention

components by exploring theories and evidence on the

educational needs of the specific target group

• In Phase I, the components were modelled in collaboration with

participants and health professionals

• In Phase II, the content and logistics of the final intervention

were refined, and supported the choice of outcomes

• The model provided the transparent and systematical

development of a well-defined intervention to be delivered in a

RCT

Financial support: University College of Jutland, Danish Council of Nursing, The Danish Diabetes Association, Novo Nordic Foundation DK

For discussion...

• Did the empirical studies of other study populations

reveal the needs of our target group sufficiently?

• Should the intervention development investigate the

reach of the specific intervention (12 weeks, group

sessions, multi-disciplinary programme)?

• Did we choose the right outcomes? –

• And should we have investigated the validity and

responsiveness of the scales?