NCT02721758

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

March 18, 2016

Last Update Submit

May 16, 2022

Conditions

Keywords

Motivational InterviewingHealth BehaviorCardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review)

    60 days after initial referral to cardiac rehabilitation program

  • Beliefs About Cardiac Rehabilitation Scale (BACR; Cooper et al., 2007)

    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)

    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)

    At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

Other Outcomes (3)

  • ENRICHD Social Support Instrument (ESSI; Mitchell et al., 2003)

    At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

  • Brief Illness Perceptions Questionnaire (BIPQ; Broadbent et al., 2006)

    At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

  • Cardiac rehabilitation adherence (# of cardiac rehabilitation sessions attended; chart review)

    Following a 12-week cardiac rehabilitation program

Study Arms (2)

Brief Motivational Intervention

EXPERIMENTAL

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

Behavioral: Brief Motivational Intervention

Usual Care

NO INTERVENTION

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

Interventions

Brief Motivational Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive or hearing impairment that would interfere with study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

MeSH Terms

Conditions

Patient ComplianceHealth Behavior

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 29, 2016

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

April 1, 2017

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations