Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr John Driver

ORCID ID

Contact details

Tees and North East Yorkshire NHS Trust
St. Luke's Hospital
Marton Road
Middlesbrough
TS26 OPT
United Kingdom
+44 01429 221438

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RRCC744F DRIVER

Study information

Scientific title

Acronym

Study hypothesis

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

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

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

10/01/1999

Overall trial end date

10/01/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Recently discharged first-time MI and CABG patients who are English speaking with no identifiable history of psychiatric illness

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/01/1999

Recruitment end date

10/01/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Tees and North East Yorkshire NHS Trust
Middlesbrough
TS26 OPT
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

Publication citations

Additional files

Editorial Notes