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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac College for Women + Usual Cardiac Rehabilitation | Experimental | Participants receive the Cardiac College for Women program in addition to usual cardiac rehabilitation care. The intervention consists of 12 structured, women-focused online education sessions delivered during the cardiac rehabilitation program. Sessions address sex- and gender-specific cardiovascular risk factors, lifestyle behaviours, psychosocial health, and self-management. Participants also receive tailored educational materials and complete a reflection diary. Usual cardiac rehabilitation includes supervised exercise, standard education, and risk factor management. |
|
| Usual Cardiac Rehabilitation | Active Comparator | Participants receive usual cardiac rehabilitation care, which includes supervised exercise, cardiovascular risk factor management, and standard group-based education sessions. Educational content covers topics such as lifestyle modification, medication adherence, and secondary prevention but is not specifically tailored to women. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of cardiac rehabilitation (approximately 12-16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of cardiac rehabilitation (approximately 12-16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial well-being | Assessed through patient-reported measures capturing emotional health, perceived support, and psychosocial factors relevant to cardiovascular disease management. | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) |
Inclusion Criteria:
Exclusion Criteria:
Participants must identify as women. This includes individuals whose gender identity aligns with being a woman, regardless of sex assigned at birth, provided they meet all other eligibility criteria and are appropriate for cardiac rehabilitation participation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela LM Ghisi, PhD | Contact | 4165973422 | 5223 | gabriela.meloghisi@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Gabriela LM Ghisi, PhD | University Health Network, Toronto | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37747380 | Background | 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. Can J Cardiol. 2023 Nov;39(11S):S375-S383. doi: 10.1016/j.cjca.2023.07.016. Epub 2023 Sep 25. | |
| 38487061 |
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De-identified individual participant data that underlie the results reported in publications (including baseline characteristics and outcome data), along with the data dictionary, will be made available. All data will be de-identified prior to sharing to protect participant confidentiality and will be shared in accordance with institutional policies, ethics approvals, and data sharing agreements.
Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Data will be available to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the principal investigator (Dr Ghisi). Data sharing will require a data use agreement and must comply with institutional and ethical guidelines. Data will be shared in de-identified form through secure transfer methods.
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D001519 | Behavior |
| D015438 | Health Behavior |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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Participants will be randomized in a 1:1 ratio to one of two parallel groups: (1) Cardiac College for Women plus usual cardiac rehabilitation, or (2) usual cardiac rehabilitation alone. The intervention is delivered over the duration of the cardiac rehabilitation program, and outcomes are assessed at baseline and at program completion. The study includes an embedded mixed-methods process evaluation to assess feasibility, implementation, and acceptability across sites.
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Due to the nature of the educational intervention, participants and care providers cannot be blinded to group allocation. Outcome data are primarily collected through self-reported questionnaires. Data analysis will be conducted using coded group assignments where feasible to minimize bias.
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| 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. |
|
| 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. | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) |
| Functional capacity | Measured using the Duke Activity Status Index (DASI), a self-reported questionnaire assessing the ability to perform daily physical activities. | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) |
| 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. | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) |
| Heart-health behaviours | Assessed through a combination of measures including physical activity (step counts), adherence to a Mediterranean-style diet, medication adherence, and self-reported lifestyle behaviours. | Baseline and end of cardiac rehabilitation (approximately 12-16 weeks) |
| Background |
| 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. |
| 36085185 | Background | 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. |
| 37984099 | Background | 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. |
| 39405590 | Background | 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. |
| 39439668 | Background | 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. |
| D000074822 | Treatment Adherence and Compliance |