- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03474185
The IMPART Study: The Impact of Patient Education in Cardiac Rehabilitation
Evaluating the Impact of Patient Education on Knowledge, Attitudes, and Adherence in Cardiac Rehabilitation Patients
Background:
Exercise-based cardiac rehabilitation (CR) is the gold-standard in tertiary prevention of coronary artery disease (CAD), yet average CR attendance is only 67%. Patient education is commonly delivered during CR to impart information about CAD and its risk factors. An underlying assumption is that knowledge will enhance patients' attitudes toward CR, promote better program adherence, and improve clinically relevant cardiovascular outcomes. However, more formative work is needed to characterize the impact of patient education delivered in a CR setting on purported mechanisms-of-action in order to optimize efficacy. Few cardiac patient education interventions have been empirically validated, and it is unclear whether knowledge gains from education translate to improved CR attitudes and program adherence.
Objective: This study aims to 1) examine the association between cardiac patient education and changes in knowledge about CAD, and; 2) explore whether changes in knowledge correspond to (a) improved attitudes about CR (perceived necessity, concerns about exercise, practical barriers, perceived personal suitability), and (b) increased CR adherence.
Hypothesis: It is expected that 1) knowledge will increase from pre- to post-patient education, and 2) knowledge gains will be associated with improved CR attitudes and better CR adherence.
Methods: 100 adults with CAD referred to outpatient CR will be recruited prior to attending four, mandatory 2.5-hour-long group-based education classes. Patients will subsequently attend supervised CR exercise sessions twice-weekly for 12 weeks. Validated questionnaires assessing knowledge about CAD and attitudes toward CR (i.e., perceived necessity, exercise concerns, barriers, perceived suitability) will be completed pre- and post-cardiac education classes, and 12-weeks post-CR. Adherence (# of CR exercise sessions attended) will be obtained by chart review.
Implications: This study will help identify whether patient education delivered in a CR setting impacts hypothesized treatment targets and inform future efforts to optimize behavioral interventions for increasing CR utilization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND & RATIONALE:
Cardiovascular disease, which includes coronary artery disease (CAD), is a leading cause of death in Canada and worldwide. Cardiac rehabilitation (CR) is the gold standard intervention for tertiary prevention of CAD, and is associated with improvements in cardiovascular risk (e.g., blood pressure, psychological distress) and with 26% reductions in mortality. Despite these benefits, only 20-50% of eligible patients participate and even fewer attend all scheduled CR sessions. CR consists of multicomponent risk reduction interventions including exercise training and patient education (PE). An underlying assumption of PE is that imparting knowledge to patients will lead to changes in their adherence to health behaviours and, ultimately, influence cardiovascular outcomes. Decades of research from behavioural science, however, demonstrates that changing health behaviours, such as CR participation, requires more than knowing "what" to do, but also favourable attitudes and self-efficacy about behaviour change. PE has been demonstrated to enhance knowledge about CAD, but more work is needed to understand whether changes in knowledge translate into more positive attitudes, self-efficacy, and adherence to CR. To date, only one Canadian PE curriculum within a CR setting has been empirically evaluated, and cardiac PE classes across settings are often poorly described and variable in duration and format. To optimize adherence to CR and its associated survival benefits, there is a need to evaluate whether a well-described cardiac PE curriculum helps translate knowledge into favourable attitudes, self-efficacy, and CR attendance.
PRIMARY AIM: To determine the impact of a Calgary-based patient education curriculum delivered in a CR setting (i.e., "Taking Charge of your Heart Health"; TCHH) on cardiac knowledge post-TCHH and at 12-week follow-up.
SECONDARY AIMS:
- To examine the impact of cardiac education on attitudes toward CR, and self-efficacy for CR attendance from pre- to post-TCHH
- To examine whether increases in CAD knowledge are associated with improvements in attitudes toward CR, self-efficacy for CR adherence from pre- to post-TCHH oTo examine whether increases in CAD knowledge from pre- to post-TCHH are associated with CR adherence
HYPOTHESES: It is predicted that (1) knowledge about CAD will increase from pre- to post-TCHH, and knowledge gains will be maintained at 12-weeks, and; (2) increases in knowledge will be positively associated with improvements in attitudes toward CR, self-efficacy toward CR participation, and actual CR adherence.
METHODS:
DESIGN: This is a prospective observational cohort study. As the cardiac education intervention is a mandatory component of participation in the CR program, the present study will observe and measure changes in CAD knowledge, CR attitudes, and CR adherence among eligible CR patients who choose to participate.
CR PROGRAM: The CR program consists of four mandatory 2.5-hour group-based cardiac education classes (focused on physiology, risk factors, medications, nutrition, exercise, and stress management) followed by 12 weeks of supervised exercise training held twice weekly. All patients enrolled in the CR program are required to complete the 4 education classes prior to starting CR exercise.
PROCEDURE:
• Patients will complete a baseline battery of validated questionnaires assessing CAD knowledge, CR attitudes, and CR self-efficacy, as well as baseline demographic and medical information prior to their first TCHH class (T1). Measures of CAD knowledge, CR attitudes, and CR self-efficacy will be re-administered post-TCHH (T2), and after completion of CR exercise training (12-weeks; T3).
DATA ANALYSIS: To evaluate the impact of patient education on knowledge, a repeated-measures ANOVA will be performed with time as the independent variable (T1, T2, T3), and CAD knowledge as the dependent variable. To evaluate the association between knowledge gains and CR attitudes, self-efficacy, and CR adherence, residualized change scores will be calculated for T1 to T2 knowledge, attitudes, and self-efficacy. The investigators will conduct separate regression models with knowledge change scores as the independent variable, and with CR attitudes change scores and CR adherence as dependent variables.
IMPLICATIONS: This study will inform strategies to help increase knowledge, and translate knowledge into exercise adherence, among patients with CAD. Given the link between CR attendance and morbidity/mortality, efforts to optimize patient education interventions and CR utilization have the potential to significantly improve cardiovascular health outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Alberta
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Calgary, Alberta, Canada, T2N 1N4
- Behavioural Medicine Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Referred to and eligible for the TotalCardiology CR program following a diagnosis of acute coronary syndrome (ACS). ACS patients will be targeted in this study because (a) they represent the most common patient group referred to TotalCardiology (~70% of referrals) and (b) patients with ACS follow an "Early Cardiac Access Clinic" stream at TCR that involves a different schedule of exercise appointments than other patient groups. Therefore recruiting ACS patients will enable a consistent CR referral and intake process across all study participants.
- Provided consent to be contacted about research studies
- Provided informed consent to participate in the study
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single Cohort
The intervention for the entire cohort will be "Taking Charge of your Heart Health" Cardiac Education Classes, delivered via four 2.5-hour group-based classes at TotalCardiology Rehabilitation in Calgary, Canada.
Classes review physiology, risk factors, medications, nutrition, exercise, and stress management.
Patients are required to complete these classes prior to starting CR exercise sessions.
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"Taking Charge of your Heart Health" patient education classes held at TotalCardiology cardiac rehabilitation in Calgary, Canada.
Consists of four, 2.5-hour long group-based classes focused on focused on physiology, risk factors, medications, nutrition, exercise, and stress management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Knowledge about Coronary Artery Disease (CAD)
Time Frame: Patients will complete the CADE-Q-SV at three time points: (T1) after referral to CR but prior to starting cardiac education classes, (T2) immediately following completion of education classes; and (T3) 12-weeks post-education classes
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Coronary Artery Disease Education Questionnaire-II (CADE-Q-SV) (de Melo Ghisi, Grace, Thomas, Evans, & Oh, 2015)
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Patients will complete the CADE-Q-SV at three time points: (T1) after referral to CR but prior to starting cardiac education classes, (T2) immediately following completion of education classes; and (T3) 12-weeks post-education classes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Beliefs and Attitudes about CR
Time Frame: Patients will complete the BACR at three time points: (T1) after referral to CR but prior to starting cardiac education classes, (T2) immediately following completion of education classes; and (T3) 12-weeks post-education classes
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Beliefs and Attitudes about CR (BACR) Scales (Cooper, Weinman, Hankins, Jackson, & Horne, 2007)
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Patients will complete the BACR at three time points: (T1) after referral to CR but prior to starting cardiac education classes, (T2) immediately following completion of education classes; and (T3) 12-weeks post-education classes
|
|
CR adherence
Time Frame: CR adherence will be measured 12-weeks following the completion of the cardiac education classes (after CR exercise is complete)
|
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CR adherence will be measured 12-weeks following the completion of the cardiac education classes (after CR exercise is complete)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tavis S Campbell, PhD., University Of Calgary
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB17-2481
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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