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View on ClinicalTrials.gov

Comparing Cardiac College for Women with Usual Cardiac Rehab Education for cardiovascular diseases

Official title: WomenFocused Education in CArdiac REhabilitation (WECARE) Pilot RCT

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

Condition: Cardiovascular DiseasesSponsor: University Health Network, TorontoTarget enrollment: 50
  • 2 groups
  • Sites in Barrie, Toronto and 1 more city
  • Recruiting
Cardiovascular Rehabilitation Program, Royal Victoria Regional Health Centre, Barrie, OntarioProgramme PREV, Lévis, QuebecUHN Cardiovascular Prevention Program, Toronto, Ontario

Interventions

  • Behavioural therapy

    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.

  • Behavioural therapy

    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.

Canadian Sites (3)

1 of 3 recruiting

  • UHN Cardiovascular Prevention Program

    Toronto, Ontario

    Recruiting
  • Cardiovascular Rehabilitation Program, Royal Victoria Regional Health Centre

    Barrie, Ontario

    Not yet recruiting
  • Programme PREV

    Lévis, Quebec

    Not yet recruiting

Eligibility Criteria

See who this study is looking for8 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Identify as a woman
  • +Aged 18 years or older
  • +EnrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in a participating cardiac rehabilitation program
  • +Diagnosis consistent with cardiac rehabilitation eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → (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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • +Able to participate in educational sessions in English or French (siteTrial siteA hospital or clinic where a study is actually run.Read more →-dependent)

Exclusion

  • 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
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is looking at how care is delivered and organised, rather than at a treatment itself.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Cardiac College for Women, together with one or more of: Usual Cardiac Rehab Education.

Registry label: A: Cardiac College for Women + Usual Cardiac Rehabilitation

Group B, the comparison group, receives Usual Cardiac Rehab Education.

Registry label: B: Usual Cardiac Rehabilitation

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study lists female participants only.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 50 people.

The study is currently expected to finish around September 2027.

The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to end of cardiac rehabilitation (approximately 12-16 weeks).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Feasibility of delivering a women-focused education program within cardiac rehabilitation — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to end of cardiac rehabilitation (approximately 12-16 weeks).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07550036 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Cardiac College for WomenBehavioural

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.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

About 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.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It lists female participants only.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to end of cardiac rehabilitation (approximately 12-16 weeks).

The study as a whole is currently expected to finish around 2027-09-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 50 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 3 locations, including: Barrie, Ontario, Canada; Toronto, Ontario, Canada; Lévis, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.