Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial
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| Tracking Information | |||||
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| First Received Date ICMJE | August 10, 2009 | ||||
| Last Updated Date | April 22, 2010 | ||||
| Start Date ICMJE | November 2008 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
CR Adherence [ Time Frame: Approximately 3-months after recruitment ] [ Designated as safety issue: No ] Number of cardiac rehabilitation classes attended in total. |
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| Original Primary Outcome Measures ICMJE |
Number of cardiac rehabilitation classes attended [ Time Frame: Around 3 months post-recruitment ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00956657 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Illness Perceptions Questionnaire-Revised Scores [ Time Frame: 3-months after consent ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE |
Illness Perceptions Questionnaire-Revised Scores [ Time Frame: 3-months after consent ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial | ||||
| Official Title ICMJE | Improving Cardiac Rehabilitation Session Attendance Using the Self-Regulatory Model and Motivational Interviewing: A Randomised Controlled Trial | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Health Services Research |
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| Condition ICMJE | Cardiac Rehabilitation | ||||
| Intervention ICMJE | Behavioral: Psychological Intervention Session
One-off session aimed at changing participants beliefs around illness control and consequences, applied using a motivational interviewing style. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 31 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00956657 | ||||
| Other Study ID Numbers ICMJE | 08/S0710/65 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gavin Taylor, Clinical Psychologist, NHS Greater Glasgow & Clyde | ||||
| Study Sponsor ICMJE | NHS Greater Glasgow and Clyde | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | NHS Greater Glasgow and Clyde | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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