Cardiovascular DiseasesWE-CARENCT07550036
WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT
A study testing Cardiac College for Women and Usual Cardiac Rehab Education in people with Cardiovascular Diseases and Heart Diseases, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Health Knowledge, Attitudes, Practice
- What is being tested?
- Cardiac College for Women and Usual Cardiac Rehab Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- 21 Aug 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Not yet recruiting
Cardiovascular Rehabilitation Program, Royal Victoria Regional Health Centre
Barrie, Ontario
Lauren Jenkinson, R.Kin, +1-705-797-3157, jenkinsonl@rvh.on.ca
Lauren Jenkinson, R.Kin
- Not yet recruiting
Programme PREV
Lévis, Quebec, G6V0M4
Andre-Anne Hebert, B.Sc R.Kin, +1 418-835-3400 ext. 15202, andree-anne.hebert.cisssca@ssss.gouv.qc.ca
Marie-Kristelle Ross, MD
- Recruiting
UHN Cardiovascular Prevention Program
Toronto, Ontario, M4G1R7
Camila Kummel Duarte, PhD, +1-416-597-3422, wecare.trial@uhn.ca
Carolina Carvalho, MD, PhD
About this study
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
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:
Read more
- 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
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Health Knowledge, Attitudes, Practice, Behavior, Health
- Being tested
- Cardiac College for Women, Usual Cardiac Rehab Education
- 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
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Behavior, Health Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac College for WomenBehavioural
Also called CCW
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.
Usual Cardiac Rehab EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Cardiac Rehab Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of cardiac rehabilitation (approximately 12-16 weeks)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and end of cardiac rehabilitation (approximately 12-16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start21 Aug 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Gabriela Melo Ghisi, University Health Network, Toronto
- Investigators
- Gabriela LM Ghisi, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550036
- Sponsor's protocol ID
- 550073
- Acronym
- WE-CARE
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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. Can J Cardiol. 2023 Nov;39(11S):S375-S383. doi: 10.1016/j.cjca.2023.07.016. Epub 2023 Sep 25.
PubMed 37747380Ghisi 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.
PubMed 38487061Ghisi 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.
PubMed 36085185Ghisi 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.
PubMed 37984099Ghisi 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.
PubMed 39405590Carson 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.
PubMed 39439668
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07550036
- Acronym / sponsor ID
- WE-CARE / 550073
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cardiac College for Women + Usual Cardiac Rehabilitation | Experimental | Behavioral: Cardiac College for Women, Behavioral: Usual Cardiac Rehab EducationParticipants 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 | Behavioral: Usual Cardiac Rehab EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac College for WomenAlso: CCWCardiac 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. | Behavioural | Cardiac College for Women + Usual Cardiac Rehabilitation |
| Usual Cardiac Rehab EducationStandard 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. | Behavioural | Cardiac College for Women + Usual Cardiac Rehabilitation, Usual Cardiac Rehabilitation |
Primary outcome
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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 37747380Ghisi 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.
- Background: PubMed 38487061Ghisi 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.
- Background: PubMed 36085185Ghisi 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.
- Background: PubMed 37984099Ghisi 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.
- Background: PubMed 39405590Ghisi 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.
- Background: PubMed 39439668Carson 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriela LM Ghisi, PhD principal investigator
University Health Network, Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac College for Women and Usual Cardiac Rehab Education in people with Cardiovascular Diseases and Heart Diseases, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela LM Ghisi, PhD (4165973422 ext. 5223, gabriela.meloghisi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of delivering a women-focused education program within cardiac rehabilitation (time frame: Baseline to end of cardiac rehabilitation (approximately 12-16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07550036, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.