Effectiveness of a home-based intervention in increasing level of compliance, and cardiac self-efficacy, and reducing anxiety and depression amongst first-time myocardial infarction (MI) and coronary artery bypass graft (CABG) patients in the first 6 weeks.
| ISRCTN | ISRCTN58458272 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58458272 |
| Secondary identifying numbers | RRCC744F DRIVER |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 11/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr John Driver
Scientific
Scientific
Tees and North East Yorkshire NHS Trust
St. Luke's Hospital
Marton Road
Middlesbrough
TS26 OPT
United Kingdom
| Phone | +44 01429 221438 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Does a time structured series of home-based interventions to recently discharged first-time MI and CABG patients, which focus on the encouragement of lifestyle changes related to diet, stress and exercise, have the effect of: raising the patients' level of compliance with the formal cardiac rehabilitation course; raising their self-efficacy for cardiac-related lifestyle change; and reducing the patients' level of anxiety and depression. The study also asks if there are any relationships between these factors, and how they might vary between the MI and CABG groups. The qualitative dimension of the study seeks to explore questions related to the experience of these patients in the immediate post-discharge period, particularly in relation to adjustment within the context of their specific socio-cultural environment. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: Heart disease |
| Intervention | 1. The experimental groups will receive a home-based intervention based on the South Tees Cardiac Rehabilitation document 'A Helping Hand to Heart Recovery', which focuses on lifestyle issues such as diet, exercise and stress management. This intervention will be built around three home visits to the patients in the experimental group at 1, 3 and 6 weeks post-discharge. 2. The control group will receive usual treatment. |
| Intervention type | Other |
| Primary outcome measure | Compliance with the formal 7-week cardiac rehabilitation course which takes place at 6 -8 weeks post discharge 1. Self-efficacy scores at 1 week and 8 weeks post discharge 2. Anxiety scores at 1 and 8 weeks post discharge 3. Depression scores at 1 and 8 weeks post discharge 4. Descriptive data generated from qualitative interviews which focus on adjustment and lifestyle change |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/01/1999 |
| Completion date | 10/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Recently discharged first-time MI and CABG patients who are English speaking with no identifiable history of psychiatric illness |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/01/1999 |
| Date of final enrolment | 10/01/2001 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Tees and North East Yorkshire NHS Trust
Middlesbrough
TS26 OPT
United Kingdom
TS26 OPT
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
