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Study identifier: NCT07313657 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Improving Care and Mental Well-Being for Adults With Heart Failure

Condition: Heart Failure · Mental Health · Stress  ·  Sponsor: Bruyère Health Research Institute.

PhaseNA
Planned participants7300
Who can joinAll sexes, 40 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Krystal Kehoe MacLeod, PhD  ·  613-862-4314  ·  kmacleod@bruyere.org

Always discuss trial participation with your own doctor first.

Locations (9)

Seaway Valley Community Health Centre (Cardiac Rehab Program)Cornwall, Ontario, CanadaRecruiting
Centre de Santé Communautaire de l'EstrieLimoges, Ontario, CanadaActive Not Recruiting
Orleans Cardiopulmonary ClinicOrléans, Ontario, CanadaRecruiting
Bruyère Health Research InstituteOttawa, Ontario, CanadaNot Yet Recruiting
Byward Family Health TeamOttawa, Ontario, CanadaNot Yet Recruiting
Montfort Hospital, and associated Aline-Chrétien Rehabilitation ClinicOttawa, Ontario, CanadaActive Not Recruiting
Ste-Anne Medical ClinicOttawa, Ontario, CanadaActive Not Recruiting
University of Ottawa Heart InstituteOttawa, Ontario, CanadaActive Not Recruiting
Winchester Memorial HospitalWinchester, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT07313657