Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436130485
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of an information leaflet informed by beliefs about causes of myocardial infarction (MI) upon patients' cardiac rehabilitation behaviours and treatments for MI.
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
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Myocardial infarction
Intervention
Random allocation to
1. Treatment a
2. Treatment b (different leaflets)
Qualitative methodology: Interviews; Questionnaire.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Attendance at cardiac rehabilitation
2. Changes in health related behaviours including
2.1. smoking
2.2. diet
2.3. exercise
2.4. changes in anxiety and depression
2.5. return to work/hobbies
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2003
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients who have had a first myocardial infarction.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/04/2003
Recruitment end date
01/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychiatry & Behavioural Sciences
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (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