Improving Care and Mental Well-Being for Adults With Heart Failure (NCT07313657)
🩺 Plain-English Summary (8th-Grade Level)
Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (4 items).
Location: Seaway Valley Community Health Centre (Cardiac Rehab Program) — Cornwall, Ontario
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Inability to provide informed consent (e.g., due to cognitive impairment or language barriers without translated support)
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (9 Sites)
- Seaway Valley Community Health Centre (Cardiac Rehab Program) — Cornwall, Ontario
- Centre de Santé Communautaire de l'Estrie — Limoges, Ontario
- Orleans Cardiopulmonary Clinic — Orléans, Ontario
- Bruyère Health Research Institute — Ottawa, Ontario
- Byward Family Health Team — Ottawa, Ontario
- Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic — Ottawa, Ontario
- Ste-Anne Medical Clinic — Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario
- Winchester Memorial Hospital — Winchester, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.