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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
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
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)
why bother about hypertension
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
why bother with hypertension
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
why poor control
Patient factors

Adherence

Side effects

Mis-match of ideals

Professional factors

Workload

Lack of professional action

Ever changing guidelines

Why poor control?
what do we know about self monitoring
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
what do we know about self management
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
theoretical basis for self management
Theoretical basis for self management

Patients

  • Increased patient involvement in management decisions will result in:
    • Cues to action Adherence
    • Increased self efficacy Behaviour change
  • Better use of medication likely to have most effect

Professionals

  • Systematic titration of medication effective
  • Evidence of clinical inertia
telemonitoring theoretical attractions
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?
rcts of telemonitoring in hypertension
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

policy
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
user input
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
the trial
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
eligibility
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
intervention
Intervention
  • Self Monitoring – 1st week of every month
intervention17
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
training
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
practice input
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
outcomes
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 sub study
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
progress to date
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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