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

Recruiting now · Not applicable

Conditions studied: Heart Failure, Mental Health, Stress, Anxiety, Depression

In brief

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.

Key facts

Study ID

NCT07313657

Run by

Bruyère Health Research Institute.

People needed

7300

Starts

2025-09-26

Expected to finish

2026-11-30

Last updated by the study team

2026-02-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For Patients (Surveys and Optional Interviews):
• 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.

You may not qualify if…

• 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

Where it is running

• Seaway Valley Community Health Centre (Cardiac Rehab Program) — Cornwall, Ontario, Canada (enrolling)
• Orleans Cardiopulmonary Clinic — Orléans, Ontario, Canada (enrolling)
• Winchester Memorial Hospital — Winchester, Ontario, Canada (enrolling)
• 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
• Centre de Santé Communautaire de l'Estrie — Limoges, Ontario, Canada
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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