Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation

Study Overview
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Brief Summary
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The purpose of this study was to test whether a brief motivational intervention is associated with enrollment in cardiac rehabilitation.

Detailed Description
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Cardiac rehabilitation programs help reduce morbidity and mortality following a cardiac event, but only a subset of referred patients chooses to participate. An intervention based on principles of motivational interviewing may help resolve individuals' ambivalence about cardiac rehabilitation. The primary aim is to evaluate the efficacy of a brief motivational intervention (MI) for enhancing intention to enroll in cardiac rehabilitation compared to a usual care (UC) control condition among patients referred to cardiac rehabilitation. It is hypothesized that patients in the MI condition will report greater intention to enroll in cardiac rehabilitation compared to patients in UC. A small-scale feasibility trial will include patients (n = 100) with acute coronary syndrome who are referred to a standard 12-week exercise-based cardiac rehabilitation program in Calgary, Canada. Patients will be randomly assigned to MI or UC. The primary outcome will be self-reported intention to attend cardiac rehabilitation. Secondary outcomes will include beliefs about cardiac rehabilitation, exercise self-efficacy, perceived barriers, and cardiac rehabilitation enrollment.

Official Title
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Design and Evaluation of a Brief Motivational Intervention to Promote Enrolment in Outpatient Cardiac Rehabilitation

Conditions
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Patient Compliance

Intervention / Treatment
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* Behavioral: Brief Motivational Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred to and eligible for outpatient, exercise-based cardiac rehabilitation; confirmed acute coronary syndrome; English-speaking; able to complete study prior to first scheduled cardiac rehabilitation appointment Exclusion Criteria: Cognitive or hearing impairment that would interfere with study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Motivational Intervention<br>Single, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing | Behavioral: Brief Motivational Intervention<br> <br> |
| No Intervention: Usual Care<br>Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention to Attend Cardiac Rehabilitation Scale (adapted from Blanchard et al., 2002) | Intention to attend cardiac rehabilitation will be assessed using the average of two self-report items: (1) My goal is to attend ___ exercise classes at cardiac rehabilitation with responses ranging from 1 (no exercise classes) to 7 (some exercise classes) and (2) I intend to attend scheduled classes during cardiac rehabilitation with responses ranging from 1 (strongly disagree) to 7 (strongly agree). Blanchard, C. M., Courneya, K. S., Rodgers, W. M., Daub, B., & Knapik, G. (2002). Determinants of exercise intention and behavior during and after phase 2 cardiac rehabilitation: An application of the theory of planned behavior. Rehabilitation Psychology, 47(3), 308-323. | At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review) | Participation in cardiac rehabilitation will be confirmed by chart review 60 days after referral. Non-enrollment will be defined as (a) explicitly declining interest in CR participation, (b) not attending the initial scheduled exercise appointment within 60 days of referral, or (c) inability to be contacted by program staff within 60 days of referral to cardiac rehabilitation. | 60 days after initial referral to cardiac rehabilitation program | 
| Beliefs About Cardiac Rehabilitation Scale (BACR; Cooper et al., 2007) | The BACR is a 13-item questionnaire that evaluates patients' beliefs regarding CR. Items are rated on a 5-point Likert-type scale, ranging from strongly disagree to strongly agree. Items are summed to provide a score on each of four subscales: perceived necessity, concerns about exercise, practical barriers, and perceived suitability. Cooper, A. F., Weinman, J., Hankins, M., Jackson, G., & Horne, R. (2007). Assessing patients' beliefs about cardiac rehabilitation as a basis for predicting attendance after acute myocardial infarction. Heart (British Cardiac Society), 93(1), 53-8. doi:10.1136/hrt.2005.081299 | At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days) | 
| Multidimensional Self-Efficacy for Exercise Scale (Rodgers et al., 2008) | The MSES is a 9-item questionnaire that evaluates exercise self-efficacy in three domains: task (e.g., ability to follow directions to complete exercise), coping (e.g., ability to exercise when feeling discomfort from exercise), and scheduling (e.g. ability to fit exercise into daily routine). Items are rated from 0 (not at all confident) to 100 (completely confident), and averaged in each domain. Rodgers, W. M., Wilson, P. M., Hall, C. R., Fraser, S. N., & Murray, T. C. (2008). Evidence for a multidimensional self-efficacy for exercise scale. Research Quarterly for Exercise and Sport, 79(2), 222-34. | At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days) | 
| Cardiac Rehabilitation Barriers Scale (CRBS; Shanmugasegaram et al., 2012) | The CRBS is a 21-item questionnaire designed to assess perceptions of patient, provider, and health system barriers to CR participation. Items are rated on 5-point Likert-type scales ranging from strongly disagree to strongly agree, and are averaged to provide a total score, with higher scores indicating greater perceived barriers. Totals are also calculated for four subscales: perceived need/healthcare factors, logistical factors, work/time conflicts, and comorbidities/functional status. Shanmugasegaram, S., Gagliese, L., Oh, P., Stewart, D. E., Brister, S. J., Chan, V., & Grace, S. L. (2012). Psychometric validation of the Cardiac Rehabilitation Barriers Scale. Clinical Rehabilitation, 26(2), 152-64. doi:10.1177/0269215511410579 | At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivational Interviewing, Health Behavior, Cardiac Rehabilitation