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
DOI	https://doi.org/10.1186/ISRCTN72884263
Protocol serial number	HTA 99/32/09
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Department of Public Health & Epidemiology
University of Birmingham
The Public Health Building
Edgebaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 7552
Email	C.B.Jolly@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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).
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	28/02/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Department of Public Health & Epidemiology

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009	Yes	No
Other publications	design and rationale at	10/09/2003	Yes	No
Other publications	recruitment analysis at	17/05/2005	Yes	No