Clinical trial NCT02721758: Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation
Official title: Design and Evaluation of a Brief Motivational Intervention to Promote Enrolment in Outpatient Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Keywords: Motivational Interviewing
Health Behavior
Cardiac Rehabilitation
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intention to Attend Cardiac Rehabilitation Scale (adapted from Blanchard et al., 2002)
timeFrame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
Secondary outcomes:
measure: Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review)
timeFrame: 60 days after initial referral to cardiac rehabilitation program
measure: Beliefs About Cardiac Rehabilitation Scale (BACR; Cooper et al., 2007)
timeFrame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
measure: Multidimensional Self-Efficacy for Exercise Scale (Rodgers et al., 2008)
timeFrame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
measure: Cardiac Rehabilitation Barriers Scale (CRBS; Shanmugasegaram et al., 2012)
timeFrame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
Other outcomes:
measure: ENRICHD Social Support Instrument (ESSI; Mitchell et al., 2003)
timeFrame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
measure: Brief Illness Perceptions Questionnaire (BIPQ; Broadbent et al., 2006)
timeFrame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
measure: Cardiac rehabilitation adherence (# of cardiac rehabilitation sessions attended; chart review)
timeFrame: Following a 12-week cardiac rehabilitation program
Locations:
city: Calgary
country: Canada
facility: Department of Psychology, University of Calgary
state: Alberta
Study officials:
References: