About this trial
The goal of this pilot clinical trial is to learn if a women-focused education program can improve knowledge, health, and well-being in women with heart disease who are attending cardiac rehabilitation. It will also help researchers understand if this program can be delivered successfully in different rehabilitation programs.
The main questions it aims to answer are:
* Is it feasible to deliver this women-focused education program within routine cardiac rehabilitation programs? * Do women who receive this program show improvements in heart health knowledge, quality of life, and healthy behaviours?
Researchers will compare women who receive the Cardiac College for Women program plus usual cardiac rehabilitation to those who receive usual cardiac rehabilitation alone to see if the program leads to better outcomes.
Participants will:
* Be randomly assigned to receive either the women-focused education program or usual care * Attend cardiac rehabilitation as part of their regular care * Complete questionnaires at the start and end of the program * (If in the intervention group) attend online education sessions and use supporting materials * (Optional) take part in a group discussion about their experience after completing the program
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Identify as a woman
Aged 18 years or older
Enrolled in a participating cardiac rehabilitation program
Diagnosis consistent with cardiac rehabilitation eligibility (e.g., coronary artery disease, myocardial infarction, revascularization procedures, spontaneous coronary artery dissection, myocardial infarction with non-obstructive coronary arteries, Takotsubo cardiomyopathy, or heart failure)
Disqualifiers
Medical, cognitive, or psychiatric conditions that would prevent participation in educational sessions or completion of study questionnaires
Inability to access or use online educational sessions or digital materials required for the intervention
Trial design
Parallel
Treatments tested in this trial
Cardiac College for Women
BehavioralCardiac College for Women is a structured, women-focused cardiovascular education program delivered online during participation in cardiac rehabilitation. It consists of 12 sessions (60 minutes each) covering sex- and gender-specific cardiovascular risk factors, healthy lifestyle behaviours, psychosocial well-being, and self-management strategies. Sessions include presentations, videos, and interactive discussions facilitated by trained cardiac rehabilitation staff. Participants also receive tailored educational materials relevant to their cardiac condition and complete a reflection diary to support learning and behaviour change. The program is delivered remotely to improve accessibility and complement usual cardiac rehabilitation care.
Usual Cardiac Rehab Education
BehavioralStandard cardiac rehabilitation education delivered as part of routine care. This includes group-based sessions covering cardiovascular risk factors, lifestyle modification, medication management, and secondary prevention. Sessions are typically delivered in mixed-gender groups and are not specifically tailored to women's cardiovascular health needs. Participants also receive supervised exercise and multidisciplinary support as part of comprehensive cardiac rehabilitation.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of delivering a women-focused education program within cardiac rehabilitation
Feasibility will be assessed using multiple indicators, including recruitment rate (proportion of eligible participants enrolled), retention rate (proportion completing follow-up assessments), intervention adherence (attendance at education sessions), intervention fidelity, and completeness of outcome data collection. These measures will determine whether a larger randomized controlled trial is practical and achievable.
Secondary outcomes
Implementation and acceptability of the intervention
Assessed through participant engagement with sessions and materials, and perceptions of relevance, usefulness, and accessibility. Healthcare provider perspectives on feasibility and integration into routine practice will also be explored using qualitative interviews and focus groups.
Disease-related knowledge
Measured using the Coronary Artery Disease Education Questionnaire - Short Version (CADE-Q SV), a validated tool assessing knowledge across domains including medical condition, risk factors, exercise, nutrition, and psychosocial health.
Functional capacity
Measured using the Duke Activity Status Index (DASI), a self-reported questionnaire assessing the ability to perform daily physical activities.
Health-related quality of life
Measured using the MacNew questionnaire, which assesses physical, emotional, and social aspects of quality of life in individuals with cardiovascular disease.
Other outcomes
Psychosocial well-being
Assessed through patient-reported measures capturing emotional health, perceived support, and psychosocial factors relevant to cardiovascular disease management.
Sponsors and contacts
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University Health Network, Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator