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TASMINH2: Telemonitoring and Self Management in Hypertension. Dr Richard McManus Clinical Senior Lecturer Department of Primary Care and General Practice University of Birmingham. Research Team. Dr Richard McManus: (CI) GP Dr Jonathan Mant: Public Health / Stroke (Prevention) Specialist

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TASMINH2: Telemonitoring and Self Management in Hypertension

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TASMINH2:Telemonitoring and Self Management in Hypertension

Dr Richard McManus

Clinical Senior Lecturer

Department of Primary Care and General Practice

University of Birmingham


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Research Team

  • Dr Richard McManus: (CI) GP

  • Dr Jonathan Mant: Public Health / Stroke (Prevention) Specialist

  • Dr Emma Vince & Dr Miren Jones (RFs)

  • Prof Richard Hobbs (Primary Care CVD)

  • Mr Roger Holder (Statistics)

  • Dr Sheila Greenfield (Sociology / Qualitative)

  • Prof Paul Little (Primary Care Trials, BP monitoring)

  • Prof Stirling Bryan (Health Economics)

  • Prof Bryan Williams (Cardiology / Hypertension)


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Why bother about hypertension?

Hypertension is important

  • Key risk factor for cardiovascular disease

  • 5mmHg reduction in systolic BP leads to reduction of stroke risk by 15-20% and coronary heart disease risk by 5-10%

    Hypertension is common

  • 30-40% of adults affected

  • Second most common reason for an adult to attend their GP

    Hypertension is poorly controlled in the community

  • 12% treated and 45% of treated controlled <140/90 mmHg


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Why bother with hypertension?

  • Treating hypertension is expensive…

    • £1-1.5 m per PCT per year in drugs alone

    • Approximately 20,000 consultations per PCT per year for treated hypertension alone

  • …But not treating it is even worse

    • Direct cost of CHD and Stroke in UK approx £4-5b / year


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Patient factors

Adherence

Side effects

Mis-match of ideals

Professional factors

Workload

Lack of professional action

Ever changing guidelines

Why poor control?


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What do we know about self monitoring?

  • First reported in 1930: Mayo Clinic

  • 19 RCTs, one UK based (TASMINH trial)

  • Most with small numbers and / or short FU

  • Bottom line to date (Cappuccio 2004)

    • SBP – 4.2 mmHg (95% CI 1.5-6.9)

    • DBP – 2.4 mmHg (1.2 – 3.5)

      (Overall standardised mean differences)

    • Nb much heterogeity between studies


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What do we know about self management?

  • Most research in other fields: arthritis, asthma, diabetes.

  • One study from Canada in hypertension suggests self management effective but trial was small and short lived.

  • Hypertension different to many other conditions due to lack of symptoms


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Theoretical basis for self management

Patients

  • Increased patient involvement in management decisions will result in:

    • Cues to action Adherence

    • Increased self efficacyBehaviour change

  • Better use of medication likely to have most effect

    Professionals

  • Systematic titration of medication effective

  • Evidence of clinical inertia


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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?


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RCTs of telemonitoring in hypertension

Friedman 1996 (US):

  • 267 subjects followed up for 6 months

  • Weekly monitoring

  • TLC system of automated feedback to patient & Dr

  • Benefit for DBP (5 mmHg) not SBP (adjustment)

    Rogers 2001 (US)

  • 121 subjects followed up for at least 8 weeks

  • Monitoring 3 days per week; feedback to physician monthly

  • Reduction in mean arterial pressure 3 mmHg

    Mehos 2000 (US) & Artinian 2001 (US) small & showed feasibility alone


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Policy

  • NSFs & associated NICE Guidelines for Hypertension, CHD, Older People (Stroke), Renal Disease & Diabetes:

    • Blood Pressure control key objective

    • Flagged up paucity of evidence for self monitoring / management

  • NHS Plan: advocates independence and patient centred care

  • National strategic programme for information technology: developing suitable technology for home monitoring

  • National Strategy for Carers: reduction of carer burden

  • Building on the Best: promoting choice of management


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User Input

  • Users involved in developing and piloting intervention

  • Recruited from TASMINH study

  • Tested different modes of self monitoring and telemonitoring

  • Piloting of research materials (questionnaires) by members of university of third age


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TASMINH2:Telemonitoring and Self Management in Hypertension


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The Trial

  • RCT: Self Management vs Usual Care

  • Patients identified by practice computer search (check for suitability)

  • Invited to attend practice based baseline clinic – eligibility, consent, questionnaires, BP measurement,

  • Randomisation to intervention or usual care

  • Practice GPs determine management


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Eligibility

  • Age 35-74

  • Treated hypertension (no more than 2 BP meds)

  • Invite on basis of practice BP reading >140/90

  • Need to have reading at baseline >140/90

  • Willing to self monitor and self titrate medication


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Intervention

  • Self Monitoring – 1st week of every month


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Intervention

  • Blood Pressure Targets:

    • NICE (140/90 or 140/80) minus 10/5

    • i.e. 130/85 or 130/75

  • 4 or more BPs per week over target for 2 months in a row triggers drug change (sticker on repeat)

  • 2 drug changes between each GP visit (ie 6m)

  • “Red zones” for very high and very low readings


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Traffic Light System


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Training

  • Two training sessions for patients to teach self monitoring and self titration

  • Assessments to ensure participants are competent in carrying out study requirements prior to starting

  • Training for practice staff regarding protocol and drug changes

  • Safety net for High / Low readings and 0800 number for queries


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Practice input

  • GP to see all patients at baseline

    • Medication Review (usual care)

    • Agree medication changes (intervention)

  • Subsequent reviews depending on BP control

    • intervention 2 changes between reviews (6mth)

    • control as per normal care

  • Review patients if very high (or low) BP


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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


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Qualitative Sub Study

  • Aims to generate data regarding the acceptability and likely generalisability of self management into daily practice

  • One to one interviews with patients, carers, health professionals and technology reps

  • Grounded theory methodology with constant comparative analysis


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Progress to date

  • Intervention developed and piloted

  • Outcome measures and trial materials finalised

  • Staff in post

  • Ethical / Trust approval in progress

  • 13 practices recruited to date

  • First Patient recruitment planned March 07


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TASMINH2:Telemonitoring and Self Management in Hypertension


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