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
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

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study acronymBRUM
Study objectivesAim:
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) studiedCardiovascular diseases: Heart disease
InterventionHospital-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 typeOther
Primary outcome measurePrimary 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 measuresNot provided at time of registration.
Overall study start date01/10/2001
Completion date28/02/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants650
Key inclusion criteriaConsecutive 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 criteriaNot provided at time of registration.
Date of first enrolment01/10/2001
Date of final enrolment28/02/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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