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Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956657
First Posted: August 11, 2009
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NHS Greater Glasgow and Clyde
  Purpose
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.

Condition Intervention
Cardiac Rehabilitation Behavioral: Psychological Intervention Session

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Health Services Research
Official Title: Improving Cardiac Rehabilitation Session Attendance Using the Self-Regulatory Model and Motivational Interviewing: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • CR Adherence [ Time Frame: Approximately 3-months after recruitment ]
    Number of cardiac rehabilitation classes attended in total.


Secondary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Psychological Intervention Session
    One-off session aimed at changing participants beliefs around illness control and consequences, applied using a motivational interviewing style.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956657


Locations
United Kingdom
Southern General Hospital
Glasgow, United Kingdom
Stobhill Infirmary
Glasgow, United Kingdom
Victoria Infirmary
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: Gavin H Taylor, MA (Hons) NHS Greater Glasgow & Clyde
  More Information

Responsible Party: Gavin Taylor, Clinical Psychologist, NHS Greater Glasgow & Clyde
ClinicalTrials.gov Identifier: NCT00956657     History of Changes
Other Study ID Numbers: 08/S0710/65
First Submitted: August 10, 2009
First Posted: August 11, 2009
Results First Submitted: March 11, 2010
Results First Posted: May 12, 2010
Last Update Posted: May 12, 2010
Last Verified: August 2009

Keywords provided by NHS Greater Glasgow and Clyde:
Randomised Controlled Trial
Adherence
Patient Participation