Patient ComplianceUPBeAT-CRNCT02721758
Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation
A study testing Brief Motivational Intervention in people with Patient Compliance, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study was to test whether a brief motivational intervention is associated with enrollment in cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Compliance
- What is being tested?
- Brief Motivational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive or hearing impairment that would interfere with study participation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Psychology, University of Calgary
Calgary, Alberta, T2N1N4
About this study
Official title: Design and Evaluation of a Brief Motivational Intervention to Promote Enrolment in Outpatient Cardiac Rehabilitation
The purpose of this study was to test whether a brief motivational intervention is associated with enrollment in cardiac rehabilitation.
Read the 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.
- Conditions
- Patient Compliance
- Being tested
- Brief Motivational Intervention
- Keywords
- Motivational Interviewing, Health Behavior, Cardiac Rehabilitation
- Medical subject headings
- Patient Compliance, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Intervention | Experimental | Single, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing Receives: Behavioral: Brief Motivational Intervention |
| Usual Care | No intervention | Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tavis S. Campbell, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721758
- Sponsor's protocol ID
- REB14-1213
- Acronym
- UPBeAT-CR
- Status last verified
- May 2022
- First submitted
- 18 Mar 2016
- Last updated
- 18 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation of a Brief Motivational Intervention to Promote Enrolment in Outpatient Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT02721758
- Acronym / sponsor ID
- UPBeAT-CR / REB14-1213
- Conditions
- Patient Compliance
- Keywords
- Motivational Interviewing, Health Behavior, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Intervention | Experimental | Behavioral: Brief Motivational InterventionSingle, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing |
| Usual Care | No intervention | –Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive or hearing impairment that would interfere with study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Motivational Intervention | Behavioural | Brief Motivational Intervention |
Primary outcome
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.
4 secondary outcomes
Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review)
Time frame: 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention in people with Patient Compliance, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.