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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. 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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  1. TASMINH2:Telemonitoring and Self Management in Hypertension Dr Richard McManus Clinical Senior Lecturer Department of Primary Care and General Practice University of Birmingham

  2. 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)

  3. 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

  4. 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

  5. Patient factors Adherence Side effects Mis-match of ideals Professional factors Workload Lack of professional action Ever changing guidelines Why poor control?

  6. 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

  7. 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

  8. 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

  9. 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?

  10. 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

  11. 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

  12. 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

  13. TASMINH2:Telemonitoring and Self Management in Hypertension

  14. 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

  15. 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

  16. Intervention • Self Monitoring – 1st week of every month

  17. 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

  18. Traffic Light System

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. TASMINH2:Telemonitoring and Self Management in Hypertension

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