Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation

NCT ID: NCT02721758

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-04-30

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.

Conditions

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Patient Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Brief Motivational Intervention

Single, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing

Group Type EXPERIMENTAL

Brief Motivational Intervention

Intervention Type BEHAVIORAL

Usual Care

Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brief Motivational Intervention

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Tavis S. Campbell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychology, University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB14-1213

Identifier Type: -

Identifier Source: org_study_id

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