WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT

Official 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

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

Detailed 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.

Interventions

• Behavioral Cardiac College for Women
  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 tai
• Behavioral Usual Cardiac Rehab Education
  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 outcome measures

• Feasibility of delivering a women-focused education program within cardiac rehabilitation [Time frame: Baseline to end of cardiac rehabilitation (approximately 12-16 weeks)]

Secondary outcome measures (5)

• Implementation and acceptability of the intervention [Time frame: End of cardiac rehabilitation (approximately 12-16 weeks)]
• Disease-related knowledge [Time frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)]
• Functional capacity [Time frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)]
• Health-related quality of life [Time frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)]
• Heart-health behaviours [Time frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Ghisi GLM, Kim WS, Cha S, Aljehani R, Cruz MMA, Vanderlei LCM, Pepera G, Liu X, Xu Z, Maskhulia L, Venturini E, Chuang HJ, Pereira DG, Trevizan PF, Kouidi E, Batalik L, Ghanbari Firoozabadi M, Burazor I, Jiandani MP, Zhang L, Tourkmani N, Grace SL. Women's Cardiac Rehabilitation Barriers: Results of the International Council of Cardiovascular Prevention and Rehabilitation's First Global Assessment PMID 37747380
• Ghisi GLM, Supervia M, Turk-Adawi K, Beleigoli A, Contractor A, Mampuya WM, Grace SL. Women-Focused Cardiac Rehabilitation Delivery Around the World and Program Enablers to Support Broader Implementation. CJC Open. 2023 Oct 14;6(2Part B):425-435. doi: 10.1016/j.cjco.2023.10.008. eCollection 2024 Feb. PMID 38487061
• Ghisi GLM, Marzolini S, Price J, Beckie TM, Mamataz T, Naheed A, Grace SL. Women-Focused Cardiovascular Rehabilitation: An International Council of Cardiovascular Prevention and Rehabilitation Clinical Practice Guideline. Can J Cardiol. 2022 Dec;38(12):1786-1798. doi: 10.1016/j.cjca.2022.06.021. Epub 2022 Aug 30. PMID 36085185
• Ghisi GLM, Hebert AA, Oh P, Colella T, Aultman C, Carvalho C, Nijhawan R, Ross MK, Grace SL. Evidence-informed development of women-focused cardiac rehabilitation education. Heart Lung. 2024 Mar-Apr;64:14-23. doi: 10.1016/j.hrtlng.2023.11.004. Epub 2023 Nov 18. PMID 37984099
• Ghisi GLM, Carson RP, Hebert AA, Ross MK, Colella TJF, Oh P, Grace SL. A multi-site prospective controlled pilot evaluation of Cardiac College for Women in the cardiac rehabilitation setting. Patient Educ Couns. 2025 Jan;130:108463. doi: 10.1016/j.pec.2024.108463. Epub 2024 Oct 9. PMID 39405590
• Carson RP, Grace SL, Bomtempo APD, Hebert AA, Ross MK, Oh P, Ghisi G. A multi-site mixed-method evaluation of 'Cardiac College for Women' implementation: perspectives of cardiac rehabilitation patients and providers. Front Cardiovasc Med. 2024 Oct 8;11:1430268. doi: 10.3389/fcvm.2024.1430268. eCollection 2024. PMID 39439668

Identifiers

NCT: NCT07550036 · 550073

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗