Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0080139149
Study information
Scientific title
A randomised controlled parallel group study of a culturally focused cardiac rehabilitation programme - an efficacy trial (CADISAP)
Acronym
Study hypothesis
To determine whether a culturally focused cardiac rehabilitation service for South Asians would be superior to conventional rehabilitation programmes.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled parallel group study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular
Intervention
Focused cardiac rehabilitation service for South Asians vs conventional rehabilitation
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Quality of life data from the SF-36 MOS, uptake and compliance in the programme are the main outcome measures to determine the differences between the two arms of the trial.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/02/2004
Overall trial end date
01/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
150 patients
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
150
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
02/02/2004
Recruitment end date
01/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Forest Healthcare
London
E11 1NR
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Whipps Cross University Hospital NHS Trust (NHS R&D Support Funding)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
British Heart Foundation
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
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