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| The Birmingham Rehabilitation Uptake Maximisation Study (BRUM). Home-based versus hospital-based cardiac rehabilitation in a multi-ethnic population: cost-effectiveness and patient adherence. |
| Source of record | UK Trials |
| ISRCTN | ISRCTN72884263 |
| Date ISRCTN assigned | 25/04/2003 |
| Local reference number(s) | HTA 99/32/09 |
| Public title | The Birmingham Rehabilitation Uptake Maximisation Study (BRUM). Home-based versus hospital-based cardiac rehabilitation in a multi-ethnic population: cost-effectiveness and patient adherence. |
| Scientific title | |
| Acronym | BRUM |
| Disease/condition/study domain | Cardiovascular diseases: Heart disease |
| Study hypothesis | Aim: What is the relative effectiveness and cost-effectiveness, taking uptake into account, of home-based versus hospital-based cardiac rehabilitation? What are reasons for non-participation? To answer these questions we will determine: 1. Whether there are differences at six months and one year following hospital- and home-based rehabilitation in: 1.1. Objective cardiac risk factors 1.2. Patient reported uptake and adherence 1.3. And whether these differ between patient groups (the elderly, women and patients from ethnic minority groups) 2. The relative costs of hospital- and home-based cardiac rehabilitation from both the patients' and NHS perspectives 3. Qualitative insights into the reasons for non-participation in the cardiac rehabilitation programmes |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Consecutive patients admitted to two acute hospitals in the West-Midlands, serving a multi-ethnic patient catchment, following myocardial infarction (MI) or revascularisation (percutaneous transluminal coronary angioplasty [PTCA]/coronary artery bypass graft [CABG]). |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material | |
| Anticipated start date | 01/10/2001 |
| Anticipated end date | 28/02/2006 |
| Status of trial | Completed |
| Target number of participants | 650 |
| Interventions | Hospital-based versus home-based cardiac rehabilitation programmes provided by specialist cardiac rehabilitation nurses. Both programmes will include exercise, relaxation, education and life-style counselling, with referral for psychological treatments as indicated. The home programme will be based around a patient-held manual (The Heart Manual for MI patients) with home visits and telephone support from the cardiac rehabilitation staff. A manual will be developed for revascularisation patients. |
| Primary outcome measure(s) | Primary outcomes at six months and one year: 1. Cardiac risk factors (serum cholesterol, blood pressure, exercise capacity measured by the shuttle test, psychological status-HADS, smoking cessation) 2. Uptake and patient reported adherence to each programme 3. Patient satisfaction and perceptions of the programmes 4. Quality of life 5. Use of secondary preventive medication 6. Health care utilisation and cardiac events Costs would be assessed from two perspectives: that of the NHS and socially. NHS costs will be based on resource inputs (time with cardiac nurses, other NHS personnel, travel time, drugs, use of other NHS services) costed up to include labour and overhead costs. Societal costs will extend NHS costs to include costs to patients and to any other relevant agencies (to be decided via patient interviews and costed as for the NHS). If the outcomes differ between the models, a cost-effectiveness evaluation will explore incremental cost-effectiveness using the outcome measures noted above. Otherwise a cost-minimisation analysis is appropriate. In either case, modelling will explore the generalisability of the results by locating the costs in a national context by collecting data from other English rehabilitation programmes by means of a survey. The results will be compared with the range of other CHD interventions, linked to work already in progress (JR's involvement in a national cost effectiveness model funded by DoH). |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Publications | 1. Design and rationale at http://www.ncbi.nlm.nih.gov/pubmed/12964946 2. Recruitment analysis at http://www.ncbi.nlm.nih.gov/pubmed/15904499 3. Results in http://www.ncbi.nlm.nih.gov/pubmed/18332063 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Department of Health (UK) |
| Sponsor details | Quarry House Quarry Hill Leeds United Kingdom LS2 7UE |
| Sponsor email | Sheila.Greener@doh.gsi.gov.uk |
| Sponsor website | http://www.dh.gov.uk/en/index.htm |
| Contact name | Dr Kate Jolly |
| Contact details | Department of Public Health & Epidemiology University of Birmingham The Public Health Building Edgebaston Birmingham United Kingdom B15 2TT |
| Contact telephone | +44 (0)121 414 7552 |
| Contact fax | +44 (0)121 414 7878 |
| Contact email | C.B.Jolly@bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN72884263 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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