- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00956657
Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial
April 22, 2010 updated by: NHS Greater Glasgow and Clyde
Improving Cardiac Rehabilitation Session Attendance Using the Self-Regulatory Model and Motivational Interviewing: A Randomised Controlled Trial
Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a long-term programme of medical evaluation, exercise, education and counseling.
National guidelines have recognized the positive impact that attendance at CR can have following heart attacks, angina and other heart problems.
Patients who attend such a programme have been shown to have reduced health problems.
Despite this, research suggests that the use of these services is poor and that the majority of patients eligible for these programmes do not continue to attend after their first class.
A range of factors have been associated with non-adherence to CR, including psychological factors such as people's beliefs about their illness.
For example, patients with high levels of perceived control over their illness after a heart attack appear to be more likely to attend CR classes than those with low levels of perceived control.
Such findings suggest that changing patients' illness beliefs, specifically those associated with illness control and illness consequences, could help to increase adherence to CR programmes.
Increased adherence to CR could improve health outcomes for patients with cardiac illnesses.
The present study is therefore investigating the effectiveness of a one-session psychological intervention, based on a theory called the Self-Regulatory Model, in altering beliefs about illness among patients starting cardiac rehabilitation.
Participants will be randomly assigned to a treatment or a non-treatment group.
It is hoped that those who receive the treatment session will attend more CR classes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Glasgow, United Kingdom
- Southern General Hospital
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Glasgow, United Kingdom
- Victoria Infirmary
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Glasgow, United Kingdom
- Stobhill Infirmary
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Attending first cardiac rehabilitation class at one of three hospital sites
- Participants had to be over 18
Exclusion Criteria:
- Unable to read and understand English information sheet and consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CR Adherence
Time Frame: Approximately 3-months after recruitment
|
Number of cardiac rehabilitation classes attended in total.
|
Approximately 3-months after recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Illness Perceptions Questionnaire-Revised Scores
Time Frame: 3-months after consent
|
Eight sub-scale scores obtained.
Sub-scales include; Illness consequences, Illness Control, Treatment Control, Illness Identity, Emotional Representation, Illness Cause, Illness Coherence, Timeline Cyclical.
Minimum and Maximum scores vary for each sub-scale.
|
3-months after consent
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gavin H Taylor, MA (Hons), NHS Greater Glasgow & Clyde
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
August 10, 2009
First Submitted That Met QC Criteria
August 10, 2009
First Posted (Estimate)
August 11, 2009
Study Record Updates
Last Update Posted (Estimate)
May 12, 2010
Last Update Submitted That Met QC Criteria
April 22, 2010
Last Verified
August 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 08/S0710/65
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.