WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT (WE-CARE)

April 17, 2026 updated by: Gabriela Melo Ghisi, University Health Network, Toronto

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:

  • 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac College for Women + Usual Cardiac Rehabilitation
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
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.
Other Names:
  • CCW
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.
Active Comparator: Usual Cardiac Rehabilitation
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of delivering a women-focused education program within cardiac rehabilitation
Time Frame: Baseline to end of cardiac rehabilitation (approximately 12-16 weeks)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation and acceptability of the intervention
Time Frame: End of cardiac rehabilitation (approximately 12-16 weeks)
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)
Disease-related knowledge
Time Frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
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
Time Frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
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
Time Frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
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
Time Frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial well-being
Time Frame: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Gabriela LM Ghisi, PhD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 550073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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