Coronary Artery Disease Clinical Trial
Official title:
Evaluating the Impact of Patient Education on Knowledge, Attitudes, and Adherence in Cardiac Rehabilitation Patients
NCT number | NCT03474185 |
Other study ID # | REB17-2481 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 28, 2018 |
Est. completion date | March 2, 2021 |
Verified date | May 2023 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 103 |
Est. completion date | March 2, 2021 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Behavioural Medicine Laboratory | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Knowledge about Coronary Artery Disease (CAD) | Coronary Artery Disease Education Questionnaire-II (CADE-Q-SV) (de Melo Ghisi, Grace, Thomas, Evans, & Oh, 2015) Questionnaire consisting of 20 True/False Items Assesses knowledge about cardiac physiology, risk factors, exercise, nutrition, and psychosocial risk Specifically designed to assess patients' knowledge during CR. Good psychometric properties. The investigators will slightly modify content to ensure match with education classes. Residualized change scores will be calculated to determine change in knowledge about CAD from pre- to post- cardiac education, and from post-education to 12-weeks (i.e., after CR exercise is complete) |
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 | |
Secondary | Changes in Beliefs and Attitudes about CR | Beliefs and Attitudes about CR (BACR) Scales (Cooper, Weinman, Hankins, Jackson, & Horne, 2007) 13 items measured on four subscales assessing attitudes about CR (perceived necessity of CR, perceived suitability) and self-efficacy for completing CR exercise (concerns about exercise, practical barriers). Patients rate their agreement/disagreement with each item (e.g., "Attending CR may help the long-term recovery of my heart condition") on a 5-point Likert-type scale with anchors at "1" (strongly disagree) and "5" (strongly agree). The BACR has established predictive validity for cardiac rehabilitation enrollment and attendance. Residualized change scores will be calculated to determine changes in BACR scores from pre- to post- cardiac education, and from post-education to 12-weeks (i.e., after CR exercise is complete) |
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 | |
Secondary | CR adherence | CR adherence is defined as # of exercise sessions attended (excluding home program) of a possible 24 offered by the CR program CR adherence will be determined by patient chart review at 12-weeks |
CR adherence will be measured 12-weeks following the completion of the cardiac education classes (after CR exercise is complete) |
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