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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00956657
Other study ID # 08/S0710/65
Secondary ID
Status Completed
Phase N/A
First received August 10, 2009
Last updated April 22, 2010
Start date November 2008
Est. completion date August 2009

Study information

Verified date August 2009
Source NHS Greater Glasgow and Clyde
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychological Intervention Session
One-off session aimed at changing participants beliefs around illness control and consequences, applied using a motivational interviewing style.

Locations

Country Name City State
United Kingdom Southern General Hospital Glasgow
United Kingdom Stobhill Infirmary Glasgow
United Kingdom Victoria Infirmary Glasgow

Sponsors (1)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary CR Adherence Number of cardiac rehabilitation classes attended in total. Approximately 3-months after recruitment No
Secondary Illness Perceptions Questionnaire-Revised Scores 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 No
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