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
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
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:
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:
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.
Inclusion Criteria:
Exclusion Criteria:
gabriela.meloghisi@uhn.ca4165973422 ext. 5223