Contact information
Type
Scientific
Primary contact
Dr Kate Jolly
ORCID ID
Contact details
Department of Public Health & Epidemiology
University of Birmingham
The Public Health Building
Edgebaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7552
C.B.Jolly@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 99/32/09
Study information
Scientific title
Acronym
BRUM
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
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2001
Overall trial end date
28/02/2006
Reason abandoned
Eligibility
Participant 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]).
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
650
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/10/2001
Recruitment end date
28/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
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Results
Jolly K, Lip GY, Taylor RS, Raftery J, Mant J, Lane D, Greenfield S, Stevens A, The Birmingham Rehabilitation Uptake Maximisation study (BRUM): a randomised controlled trial comparing home-based with centre-based cardiac rehabilitation., Heart, 2009, 95, 1, 36-42, doi: 10.1136/hrt.2007.127209.
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Jolly K, Lip GY, Sandercock J, Greenfield SM, Raftery JP, Mant J, Taylor R, Lane D, Lee KW, Stevens AJ, Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM): a randomised controlled trial [ISRCTN72884263]., BMC Cardiovasc Disord, 2003, 3, 10, doi: 10.1186/1471-2261-3-10.
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Jolly K, Lip GY, Taylor RS, Mant JW, Lane DA, Lee KW, Stevens AJ, , Recruitment of ethnic minority patients to a cardiac rehabilitation trial: the Birmingham Rehabilitation Uptake Maximisation (BRUM) study [ISRCTN72884263]., BMC Med Res Methodol, 2005, 5, 18, doi: 10.1186/1471-2288-5-18.