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Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention
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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 26, 2025
Primary Completion Date
November 30, 2026
Completion Date
November 30, 2026
Last Updated
February 17, 2026
7,300
ESTIMATED participants
Heart Failure and Mental Health Intervention (FRAME)
OTHER
Lead Sponsor
Bruyère Health Research Institute.
Collaborators
NCT07360600
NCT07485673
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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