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
Protocol serial number	RRCC744F DRIVER
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

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

Tees and North East Yorkshire NHS Trust
St. Luke's Hospital
Marton Road
Middlesbrough
TS26 OPT
United Kingdom

Phone	+44 01429 221438

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	10/01/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

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	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes