WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Health Network, Toronto

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cardiac College for Women

    Behavioral

    Cardiac 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

    Behavioral

    Standard 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

50 Participants
are divided into 2 treatment groups
Group A: Cardiac College for Women + Usual Cardiac RehabilitationExperimental treatment 2 interventions
Group B: Usual Cardiac RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to end of cardiac rehabilitation (approximately 12-16 weeks)

Secondary outcomes

1

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.

Time frame
End of cardiac rehabilitation (approximately 12-16 weeks)
2

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.

Time frame
Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
3

Functional capacity

Measured using the Duke Activity Status Index (DASI), a self-reported questionnaire assessing the ability to perform daily physical activities.

Time frame
Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
4

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.

Time frame
Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)

Other outcomes

1

Psychosocial well-being

Assessed through patient-reported measures capturing emotional health, perceived support, and psychosocial factors relevant to cardiovascular disease management.

Time frame
Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)

Sponsors and contacts

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University Health Network, Toronto

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator