- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02721758
Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation (UPBeAT-CR)
Design and Evaluation of a Brief Motivational Intervention to Promote Enrolment in Outpatient Cardiac Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N1N4
- Department of Psychology, University of Calgary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Motivational Intervention
Single, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing
|
|
No Intervention: Usual Care
Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention to Attend Cardiac Rehabilitation Scale (adapted from Blanchard et al., 2002)
Time Frame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
|
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)
Time Frame: 60 days after initial referral to cardiac rehabilitation program
|
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)
Time Frame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
|
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)
Time Frame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
|
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)
Time Frame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ENRICHD Social Support Instrument (ESSI; Mitchell et al., 2003)
Time Frame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
|
The ESSI is a 7-item questionnaire designed to assess social support in patients post-myocardial infarction. Items are rated from 1 (none of the time) to 5 (all of the time), and are summed to provide a total score, with higher scores indicating more social support. Mitchell, P. H., Powell, L., Blumenthal, J., Norten, J., Ironson, G., Pitula, C. R., ... & Berkman, L. F. (2003). A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. Journal of Cardiopulmonary Rehabilitation and Prevention, 23(6), 398-403. |
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)
Time Frame: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
|
The BIPQ is an 8-item questionnaire that assesses cognitive and emotional representations of illness. It evaluates perceived consequences, timelines, personal/treatment control, symptoms, concern, understanding, and emotional consequences associated with the illness. Items are summed to provide a total score, with higher scores indicating greater perceived threat of the illness. Broadbent, E., Petrie, K. J., Main, J., & Weinman, J. (2006). The brief illness perception questionnaire. Journal of Psychosomatic Research, 60(6), 631-7. doi:10.1016/j.jpsychores.2005.10.020 |
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)
Time Frame: Following a 12-week cardiac rehabilitation program
|
Number of cardiac rehabilitation sessions attended (out of a total possible 24 scheduled sessions)
|
Following a 12-week cardiac rehabilitation program
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REB14-1213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patient Compliance
-
HaEmek Medical Center, IsraelUnknownPatient Satisfaction | Patient Compliance
-
University of AarhusUnknownPatient Engagement | Patient Empowerment | Patient Compliance
-
University of Illinois at Urbana-ChampaignNational Institute on Aging (NIA)Completed
-
Coloplast A/SCompletedCompliance, PatientDenmark
-
Arizona State UniversityNational Institute on Drug Abuse (NIDA); Mesa Public SchoolsCompletedPatient ComplianceUnited States
-
Norwegian Medical AssociationCompleted
-
Xijing Hospital of Digestive DiseasesRecruiting
-
Shara Qadir HusseinCompleted
-
Mansoura UniversityCompleted
-
E-DA HospitalUnknownCompliance, Patient
Clinical Trials on Brief Motivational Intervention
-
Rhode Island HospitalNational Institute on Drug Abuse (NIDA)CompletedHepatitis C | HIV | Drug UseUnited States
-
Centers for Disease Control and PreventionUnknownAccidents, Traffic
-
Rhode Island HospitalNational Institute on Drug Abuse (NIDA)CompletedHIV Infections | Hepatitis B | Hepatitis C | HIV | Substance Abuse Detection | Brief InterventionUnited States
-
Wayne State UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Friends Research Institute, Inc.National Institute on Drug Abuse (NIDA)CompletedRisk Behavior | Marijuana Use | Alcohol Consumption | Unsafe Sex
-
Brigham and Women's HospitalCompletedMotivational Interviewing | Advance Care Planning | Emergency Service, HospitalUnited States
-
University of PittsburghCompletedBipolar Disorder | Medication AdherenceUnited States
-
Centers for Disease Control and PreventionTulane University School of Public Health and Tropical MedicineSuspendedBacterial Vaginosis | Vaginal DouchingUnited States
-
University of ExtremaduraCompleted
-
University of Missouri-ColumbiaCompletedPhysical Inactivity | Poor DietUnited States