WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT

NCT07550036 | Not Yet Recruiting

• 1 other identifier: 550073
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cardiovascular Diseases; Heart Diseases; Health Knowledge, Attitudes, Practice; Behavior, Health

Keywords

Cardiac Rehabilitation; Women's Health; Patient Education; Cardiovascular Disease Prevention; Secondary Prevention; Health Education; Women-Focused Care; Gender-Specific Care; Digital Health / Virtual Care; Self-Management; Health Behaviour Change; Quality of Life; Feasibility Study; Pilot Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Implementation and acceptability of the intervention

  End of cardiac rehabilitation (approximately 12-16 weeks)

• Disease-related knowledge

  Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)

• Functional capacity

  Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)

• Health-related quality of life

  Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)

• Heart-health behaviours

  Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)

Other Outcomes (1)

• Psychosocial well-being

  Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)

Study Arms (2)

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.

Behavioral: Cardiac College for Women; Behavioral: Usual Cardiac Rehab Education

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.

Behavioral: Usual Cardiac Rehab Education

Interventions

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.

Also known as: CCW

Cardiac College for Women + Usual Cardiac Rehabilitation

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.

Cardiac College for Women + Usual Cardiac Rehabilitation; Usual Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Related Publications (6)

• 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.

  PMID: 37747380 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.

  PMID: 38487061 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.

  PMID: 36085185 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.

  PMID: 37984099 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.

  PMID: 39405590 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.

  PMID: 39439668 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Behavior; Health Behavior; Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Study Officials

• Gabriela LM Ghisi, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela LM Ghisi, PhD

CONTACT

4165973422; gabriela.meloghisi@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Scientist

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.