An interventional study of Cardiac College for Women and Usual Cardiac Rehab Education in Cardiovascular Diseases, Heart Diseases and Health Knowledge, Attitudes, Practice, sponsored by University Health Network, Toronto. Recruiting at 3 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Health services research
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.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's planned enrollment of 50 is below the median of 129 across 931 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Compared within Heart Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Cardiac College for Women · Behavioral: Usual Cardiac Rehab Education
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.
Behavioral: Usual Cardiac Rehab Education
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.
Also known as: CCW
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.
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.
Time frame: Baseline to end of cardiac rehabilitation (approximately 12-16 weeks)
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.
Time frame: End of cardiac rehabilitation (approximately 12-16 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
Psychosocial well-being
Assessed through patient-reported measures capturing emotional health, perceived support, and psychosocial factors relevant to cardiovascular disease management.
Time frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Access criteria: 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.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2027, 10 months after the start.
Of 263 non-industry interventional studies with no phase under Heart Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 10 months is below that.
Counting every sponsor, half of 336 studies reached it within 25 months; a quarter within 10 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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