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WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT

WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

Description

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.

Eligibility

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

Study details
    Cardiovascular Diseases
    Heart Diseases
    Health Knowledge
    Attitudes
    Practice
    Behavior
    Health

NCT07550036

University Health Network, Toronto

20 October 2026

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