Improving Care and Mental Well-Being for Adults With Heart Failure
NCT ID: NCT07313657
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
7300 participants
INTERVENTIONAL
2025-09-26
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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FRAME Intervention
Every participant who completed the intake survey for baseline data collection will receive the FRAME intervention via email in January 2026.
Heart Failure and Mental Health Intervention (FRAME)
Foundation, Recognition, Awareness, Management and Engagement (FRAME) is a multi-component, co-designed web tool created in collaboration with patient partners, caregivers, healthcare providers, and Archipel and Great River Ontario Health Teams. It is designed to improve recognition, awareness, management and support for mental health in patients with heart failure. There are three different versions: one for healthcare providers, one for caregivers and one for patients. The intervention includes educational material about heart failure and mental health, conversational support to help facilitate discussions about mental health, self-management activity maps (e.g., tips about nutrition and exercise), asset maps (i.e., displaying available resources), and the provider-facing discussion tool to help initiate conversations about mental health and guide referrals or supports. FRAME was developed through a co-design process informed by the lived experiences of community partners.
Interventions
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Heart Failure and Mental Health Intervention (FRAME)
Foundation, Recognition, Awareness, Management and Engagement (FRAME) is a multi-component, co-designed web tool created in collaboration with patient partners, caregivers, healthcare providers, and Archipel and Great River Ontario Health Teams. It is designed to improve recognition, awareness, management and support for mental health in patients with heart failure. There are three different versions: one for healthcare providers, one for caregivers and one for patients. The intervention includes educational material about heart failure and mental health, conversational support to help facilitate discussions about mental health, self-management activity maps (e.g., tips about nutrition and exercise), asset maps (i.e., displaying available resources), and the provider-facing discussion tool to help initiate conversations about mental health and guide referrals or supports. FRAME was developed through a co-design process informed by the lived experiences of community partners.
Eligibility Criteria
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Inclusion Criteria
* Patients at risk of heart failure (e.g., irregular heartbeat, coronary artery disease, a past heart attack, high blood pressure that is being treated, cardiomyopathy), or with a self-reported/documented diagnosis of heart failure OR on the following list of medications :
* Angiotensin receptor-neprilysin inhibitors (ARNI), called sacubitril-valsartan
* Angiotensin converting enzyme inhibitors (ACEi), called "prils"
* Angiotensin-receptor blockers (ARBs), called "sartans"
* Beta-blockers, called "lols"
* Mineralocorticoid receptor antagonists (MRAs)
* Sodium-glucose co-transporter-2 (SGLT2) inhibitors, called "flozins"
* Receiving care at one of the participating pilot test sites or if they found their way to the tool website
* Willing and able to provide informed consent and name, email address and phone number for follow-up contact (for survey and interview)
Caregivers (Optional interviews):
* Caregivers who support adult(s) with heart failure.
Exclusion Criteria
* Participants who do not have access to the internet will not be able to use the web-tool.
For Healthcare Providers
* Providers that are not involved in the care of heart failure patients
40 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Bruyère Health Research Institute.
OTHER
Responsible Party
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Locations
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Seaway Valley Community Health Centre (Cardiac Rehab Program)
Cornwall, Ontario, Canada
Centre de Santé Communautaire de l'Estrie
Limoges, Ontario, Canada
Orleans Cardiopulmonary Clinic
Orléans, Ontario, Canada
Bruyère Health Research Institute
Ottawa, Ontario, Canada
Byward Family Health Team
Ottawa, Ontario, Canada
Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic
Ottawa, Ontario, Canada
Ste-Anne Medical Clinic
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Winchester Memorial Hospital
Winchester, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Project Background and Information from the Research Team conducting this study
Project Background and Information from the Brain-Heart Interconnectome at the University of Ottawa
Other Identifiers
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M16-25-028
Identifier Type: -
Identifier Source: org_study_id
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