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NCT Number: NCT07550036

WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT

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

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Key information

About this study

Cardiovascular disease remains the leading cause of death among women worldwide. Despite strong evidence supporting the benefits of cardiac rehabilitation, women are less likely than men to be referred, enroll, and complete these programs. Multiple barriers contribute to this gap, including caregiving responsibilities, work demands, limited awareness of benefits, and psychosocial challenges. In addition, most cardiac rehabilitation programs provide standardized, mixed-gender education that does not address sex- and gender-specific aspects of cardiovascular disease. As a result, important topics relevant to women - such as unique risk factors, symptom presentation, and psychosocial experiences - may be underrepresented.

Patient education is a central component of cardiac rehabilitation and plays a key role in improving disease knowledge, supporting self-management, and promoting healthy behaviours. Evidence suggests that tailored education may enhance engagement and better meet the needs of specific populations. Women-focused cardiac rehabilitation approaches have shown promise in improving satisfaction, adherence, and patient-centred outcomes; however, access to structured, evidence-based educational programs designed specifically for women remains limited.

Cardiac College for Women is a women-tailored educational program developed to address these gaps. It is based on established patient education principles and health behaviour theories and was created through an iterative process incorporating research evidence, clinical expertise, and input from women with lived experience of cardiovascular disease. The program is designed to be delivered remotely alongside routine cardiac rehabilitation, offering flexibility and addressing common barriers to participation such as time constraints and transportation.

Preliminary research has demonstrated that women participating in this program show improvements in disease-related knowledge, quality of life, and health behaviours, along with high levels of satisfaction and engagement. However, prior evaluations have not used a randomized design, and further research is needed to determine whether the program can be implemented effectively across different settings and integrated into routine care.

The purpose of this study is to evaluate the feasibility of conducting a multicentre randomized controlled trial of Cardiac College for Women within cardiac rehabilitation programs. This includes assessing the ability to recruit and retain participants, deliver the intervention as intended, and collect study data across sites. In addition, the study will explore how women and healthcare providers experience the program and its integration into clinical practice.

This pilot randomized controlled trial will compare a women-focused education program delivered alongside usual cardiac rehabilitation to usual cardiac rehabilitation alone. The study is designed to generate important feasibility data and preliminary insights that will inform the design of a larger, definitive trial. Ultimately, this research aims to support the development of more inclusive, gender-responsive cardiac rehabilitation models and improve access to tailored education for women with cardiovascular disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Able to provide informed consent
  • Able to participate in educational sessions in English or French (site-dependent)

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: CCW

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.

Primary outcomes

  1. Feasibility of delivering a women-focused education program within cardiac rehabilitation

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

    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

  1. Implementation and acceptability of the intervention

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

    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.

  2. Disease-related knowledge

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

    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.

  3. Functional capacity

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

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

  4. Health-related quality of life

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

    Measured using the MacNew questionnaire, which assesses physical, emotional, and social aspects of quality of life in individuals with cardiovascular disease.

  5. Heart-health behaviours

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

    Assessed through a combination of measures including physical activity (step counts), adherence to a Mediterranean-style diet, medication adherence, and self-reported lifestyle behaviours.

Other outcomes

  1. Psychosocial well-being

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela LM Ghisi, PhD

CONTACT

[email protected]

4165973422 ext. 5223

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Women Education in CArdiac REhabilitation (WE CARE): a Pilot Randomized Controlled Trial for Effectiveness, Implementation, Utilization, and Acceptability of Cardiac College for Women Across Canada

Acronym: WE-CARE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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