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ISRCTN
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ISRCTN72884263
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ClinicalTrials.gov identifier
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Public title
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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.
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Scientific title
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Acronym
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BRUM
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Serial number at source
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HTA 99/32/09
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular diseases: Heart disease
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Participants - inclusion criteria
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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]).
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/10/2001
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Anticipated end date
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28/02/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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650
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2003 design and rationale at http://www.ncbi.nlm.nih.gov/pubmed/12964946
2005 recruitment analysis at http://www.ncbi.nlm.nih.gov/pubmed/15904499
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18332063
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Contact name
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Dr
Kate
Jolly
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Address
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Department of Public Health & Epidemiology
University of Birmingham
The Public Health Building
Edgebaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 7552
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Fax
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+44 (0)121 414 7878
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Email
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C.B.Jolly@bham.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)1132 545 843
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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26/08/2009
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Date ISRCTN assigned
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25/04/2003
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