The Birmingham Rehabilitation Uptake Maximisation Study (BRUM). Home-based versus hospital-based cardiac rehabilitation in a multi-ethnic population: cost-effectiveness and patient adherence.
ISRCTN | ISRCTN72884263 |
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DOI | https://doi.org/10.1186/ISRCTN72884263 |
Secondary identifying numbers | HTA 99/32/09 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 26/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kate Jolly
Scientific
Scientific
Department of Public Health & Epidemiology
University of Birmingham
The Public Health Building
Edgebaston
Birmingham
B15 2TT
United Kingdom
Phone | +44 (0)121 414 7552 |
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C.B.Jolly@bham.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Scientific title | |
Study acronym | BRUM |
Study objectives | 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 |
Ethics approval(s) | Not provided at time of registration. |
Health condition(s) or problem(s) studied | Cardiovascular diseases: Heart disease |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | 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 measures | Not provided at time of registration. |
Overall study start date | 01/10/2001 |
Completion date | 28/02/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 650 |
Key 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]). |
Key exclusion criteria | Not provided at time of registration. |
Date of first enrolment | 01/10/2001 |
Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Phone | +44 (0)1132 545 843 |
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Sheila.Greener@doh.gsi.gov.uk | |
Website | http://www.dh.gov.uk/en/index.htm |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Other publications | design and rationale at | 10/09/2003 | Yes | No | |
Other publications | recruitment analysis at | 17/05/2005 | Yes | No | |
Results article | results | 01/01/2009 | Yes | No |