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Peer Support Program for Women with Heart Disease
N/A
Recruiting
Led By Kerri Mullen
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women available to participate over the next 6 months
Women able to read and understand English or French
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 26 follow up
Awards & highlights
Study Summary
This trial will help to improve the care of women with heart disease by providing evidence about an innovative program that has the potential to improve their psychosocial well-being and reduce their risk of future cardiac events.
Who is the study for?
This trial is for English or French-speaking women over 18 in Ontario with stable coronary heart disease (CHD) who've been hospitalized at UOHI within the past year. They should be eligible for health insurance, able to participate for 6 months, and provide consent. Women with certain other heart conditions or psychiatric illnesses that could interfere are excluded.Check my eligibility
What is being tested?
The study tests the Women@Heart (W@H) program, which offers peer support by women who have recovered from a heart event. It aims to see if this improves psychosocial well-being compared to those on a waiting list and also looks at its impact on health behaviors, risk factors, and clinical outcomes.See study design
What are the potential side effects?
Since W@H is a social support program rather than a medical treatment, it does not have physical side effects like drugs do. However, participants may experience emotional responses as they discuss their experiences with peers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman available for the next 6 months.
Select...
I can read and understand English or French.
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I am a woman aged 18 or older.
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I am a woman who can understand and agree to the study's requirements.
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I am a woman who was hospitalized for heart disease at UOHI in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 26 follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 26 follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Psychosocial well-being as measured by a total composite score
Secondary outcome measures
Fruit/Vegetable consumption
Gender Role Identity
Medication Adherence
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants in the W@H group will be assembled in small groups of 6-12 participants and attend 12-biweekly sessions over a 24-week intervention period. The sessions will be led by a trained peer leader and will be held in a variety of convenient locations in close geographic proximity to participants' home postal codes. Participants will receive a manual containing copies of learning exercises and educational material. Session content is focused on: emotional support (sharing your story, road to recovery, exploration of feelings, coping with changes, emotional management, coping with distress, effective communication, empowerment); informational support (self care behaviours, risk factor education and management, health care system and community resource navigation); and appraisal support (goal setting, action planning, problem solving, relapse prevention).
Group II: ControlActive Control1 Intervention
Participants in the control group will be eligible to participate in the study, but cannot participate because there are no groups within their geographical region. They will be offered the W@H program after their 26-week follow up.
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,334 Total Patients Enrolled
Kerri MullenPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
57 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman available for the next 6 months.I can read and understand English or French.I am a woman aged 18 or older.I have been hospitalized for heart valve issues or other specific heart conditions.I am a woman who can understand and agree to the study's requirements.I am a woman who was hospitalized for heart disease at UOHI in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an enrollment period for this experiment?
"Per clinicaltrials.gov, this research project is actively soliciting participants since its initial posting on January 1st 2018 and most recent update on October 13th 2022."
Answered by AI
What is the aggregate number of participants enrolled in this clinical experiment?
"Indeed, clinicaltrials.gov reveals that this research project has been open for recruitment since its launch on the 1st of January 2018 and was last updated on October 13th 2022. It is seeking to recruit a total of 240 individuals from 1 site."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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