DEPARTMENT OF PRIMARY HEALTH CARE SCIENCES

Telemonitoring and self-

management of hypertension

in primary care.

Prof Richard McManus Richard McManus has received BP monitoring equipment for

research studies from Omron and Lloyds Pharmacy

Overview

Introduction & rationale

The TASMINH2 Trial:

Telemonitoring and self-management

How does telemonitoring fit into

hypertension care?

Self monitoring in hypertension

First reported in 1930 at the Mayo Clinic:

A 25 year old “intelligent male patient” –

monitored 3x per day for three years

Variation in BP observed with

– diet

– seasons

– weekends (“diversions of a young man” !)

Self monitoring background

First Trials in 1970s

Initial work largely relied on manual anaeroid

sphygmomanometers

Not until advent of accurate automated

sphygmomanometers did consumer market take off

(2000s)

Self monitoring background

First Trials in 1970s

Initial work largely relied on manual anaeroid

sphygmomanometers

Not until advent of accurate automated

sphygmomanometers did consumer market take off

(2000s)

Now widespread use by people with hypertension:

– US 55% self monitor

– Italy 75% self monitor

– UK 30% self monitor (primary care)

Many patients do not tell their physicians

Self-monitoring – who’s using it?

Survey of 625 GPs in UK (2011)

– 90% had patients who self monitor

– Self-monitoring for diagnosis - 37%

– Self-monitoring for management - 83%

– Telemonitoring for BP not widely available

Self-monitoring effects

Bray et al. Annals of Medicine 2010

Overall self-monitoring

reduces

– SBP by 3.8 mmHg

– DBP by 1.5 mmHg

Co-intervention present vs not

5.3 mmHg

2.5 mmHg

Weighted Mean diff.-30 -15 0 15 30

Study % Weight

Weighted Mean diff.

(95% CI)

-10.10 (-20.61,0.41) Mehos (2000) 5.4

-9.30 (-11.80,-6.80) Green b (2008) 15.3

-4.40 (-10.52,1.72) Zillich (2005) 9.9

-2.00 (-16.33,12.33) Broege(2001) 3.4

-25.60 (-41.78,-9.42) Artinian (2001) 2.8

-8.50 (-14.16,-2.84) Rudd (2004) 10.5

-3.40 (-5.91,-0.89) Green a (2008) 15.2

-0.20 (-3.84,3.44) Parati (2009) 13.6

-5.00 (-10.45,0.45) Mulhauser (1993) 10.8

-0.90 (-4.98,3.18) Freidman (1996) 12.9

-5.29 (-8.26,-2.32) Overall (95% CI)

Weighted Mean diff.-30 -15 0 15 30

Study % Weight

Weighted Mean diff.

(95% CI)

-0.14 (-2.05,1.77) Baque (2005) 15.3

5.00 (-6.07,16.07) Bailey (1999) 2.5

0.50 (-3.65,4.65) Verberk (2007) 9.8

-18.00 (-27.13,-8.87) Binstock (1988) 3.5

-2.30 (-5.47,0.87) McManus (2005) 12.1

-4.60 (-9.01,-0.19) Marquez-Contreras (2006) 9.2

-2.60 (-7.26,2.06) Midanik (1991) 8.7

-3.30 (-6.77,0.17) Soghikan (1992) 11.3

-0.50 (-3.07,2.07) Vetter (2000) 13.6

-3.10 (-7.93,1.73) Halme (2005) 8.4

-7.50 (-14.28,-0.72) Carnaham (1975) 5.5

-2.52 (-4.43,-0.61) Overall (95% CI)

What’s a co-intervention?

Telemonitoring

Self Management

Nurses

Patient Education

Telemonitoring – theoretical attractions

Feedback to GP – opportunity to intervene

Promotes Dr / patient partnership

Self monitoring more frequent but information

management issue

Automated feedback possible

Reduce carer burden

Better control than self monitoring alone?

Might self-management be an effective

co-intervention?

Most research in other fields:

arthritis, asthma, diabetes

Greatest effects where combined with

self-titration

Hypertension different to many other

conditions due to lack of symptoms but

clinical inertia common place

One study from Canada in hypertension

suggested self management effective but trial

was small and short lived.

Could telemonitoring support

self-management?

McManus et al Lancet 2010

TASMINH2 Research Questions

Does self management with telemonitoring and titration of antihypertensive medication by people with poorly controlled treated hypertension result in:

1. Better control of blood pressure?

2. Changes in reported adverse events or health behaviours or costs?

3. Is it achievable in routine practice and is it acceptable to patients?

The Trial

Eligibility

– Age 35-85

– Treated hypertension (no more than 2 BP meds)

– Baseline BP >140/90 mmHg

– Willing to self monitor and self titrate medication

Patients individually randomised to self-management vs usual care stratified by practice and minimised on sex, baseline SBP, DM status,

Practice GPs determine management

Intervention

Self Monitoring – 1st week of every month

Intervention

Blood Pressure Targets:

– NICE (140/90 or 140/80 mmHg)

– minus 10/5 mmHg i.e. 130/85 mmHg or 130/75 mmHg

Patients agreed titration schedule with their GP after randomisation

Traffic Light system to adjust medication

Outcomes

Follow up at 6 & 12 months

Main outcome Systolic Blood Pressure

Secondary outcomes: Diastolic BP / costs /

anxiety / health behaviours/ patient

preferences / systems impact

Recruitment target 480 patients (240 x 2)

Sufficient to detect 5mmHg difference

between groups

Qualitative study - methods

Purposive selection of intervention patients for interview – Age, gender, deprivation, surgery, BP change, medication change(s)

Semi-structured interviews in patient‟s home

Topics covered: – Knowledge and understanding of BP

– Experience of the trial

– Preference for self management v usual care

Interviews audio-taped and transcribed

Analysis by constant comparative method

Results

Invited (n = 7637)

Declined Invitation

(n = 5987)

Assessed for eligibility (n = 1650)

Excluded (n = 1123) Not Eligible (n = 1044)

Declined to participate (n=79)

Control (n = 264) Received usual care

(n = 264)

Randomised (n = 527)

Analysed (n = 246) Incomplete cases excluded

(n = 18)

Did not attend follow up

(n=14)*

Discontinued usual care

(n = 0)

Intervention (n = 263) Received intervention

training (n = 241)

Did not attend follow up

(n=26)#

Discontinued intervention

(n = 53)

Analysed (n = 234) Incomplete cases excluded

(n = 29)

110% recruitment

91% follow up

80% completed

intervention

Baseline Results

Results - primary outcome SBP

Results - medications

212 (80%) self managed for full 12 months

148 (70%) made at least one

medication change

At 12m intervention group prescribed

0.46 (0.34, 0.58) additional antiHT (p=0.001)

Main changes seen in thiazides and

calcium channel blockers

(60% on ACEI/ARB at baseline)

Results – side effects

Similar side effects in intervention vs control

Results - costs

Results – cost effectiveness

Mean ICER of €22/mm Hg or €9500/QALY

-£200

-£100

£0

£100

£200

£300

£400

-0.02 -0.01 0 0.01 0.02 0.03 0.04 0.05 0.06

Difference in QALY gain

Co

st

dif

fere

nce

Results – Interviews (Monitoring)

Patients generally positive about self-monitoring

Surprised at difference between home and

surgery readings

Majority thought that monitoring for 1 week/month

was „about right‟, but some found it excessive

Most managed telemonitoring but failure in

approx 10%

Jones BJGP 2012

Results – Interviews (Medication)

Patients did not like having to take medication but

accepted they had to

All said they took their medication regularly

Patients more comfortable about making a

medication change if their BP readings were

substantially above target

Patients reluctant to implement a medication

change if only just raised and several chose not to

Bottom line

Self Management & telemonitoring results in

significantly lower blood pressure than usual care

which is sustained after 12 months

Increased medication likely to be main

mechanism

Cost effective under UK criteria

Impact of telemonitoring largely as safety net

Patients are willing to be more involved in

decisions on medication

How does this fit in with the

literature?

Omboni Telemonitoring SR AJH 2011

12 studies

Mean reduction clinic BP with telemonitoring 5.6/2.8 mmHg (11 comparisons)

Less effect on ABP: 2.3/1.4 mmHg (3 comparisons)

Evidence that effects = due to better drug titration

Significant heterogeneity and evidence of reporting bias for negative studies

At least two more studies since have shown greater ABP reductions

Telemonitoring in hypertension

conclusions

Feedback to physician X not enough alone

Promotes Dr / patient partnership yes

Self monitoring more frequent but information

management issue / X needs integration

Automated feedback possible yes

Reduce carer burden / X not yet clear

Better control vs self monitoring alone? yes

Acknowledgements

Prof Jonathan Mant Dr Emma Bray Dr Miren Jones Amanda Davies Miriam Banting Roger Holder Billy Kaambwa Dr Sheila Greenfield Prof Paul Little Prof Stirling Bryan Prof Bryan Williams Prof Richard Hobbs

Acknowledgements

•This work was commissioned and funded by the Policy Research

Programme of the Department of Health,

•It received joint funding from the NIHR National Coordinating

Centre for Research Capacity Development and Midlands

Research Practices Consortium (MidReC).

•Service support costs were obtained from the Department of

Health in collaboration with MidReC.

•Views expressed are not necessarily those of the DoH

•The work would not have been possible without the collaboration

of both patients and practices whom we thank.

DEPARTMENT OF PRIMARY HEALTH CARE SCIENCES

Telemonitoring and self-

management of hypertension

in primary care.

Prof Richard McManus