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

Bruyère Health Research Institute.

Status: Enrolling

Conditions: Depression; Heart Failure; Anxiety; Stress; Mental Health

Treatments: Other: Heart Failure and Mental Health Intervention (FRAME)

Study type: Interventional

Funder types: Other

Identifiers

NCT07313657

M16-25-028

Details and patient eligibility

About

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.

Enrollment: 7,300 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7,300 participants in 1 patient group

FRAME Intervention

Other group

Description:

Every participant who completed the intake survey for baseline data collection will receive the FRAME intervention via email in January 2026.

Treatment:

Other: Heart Failure and Mental Health Intervention (FRAME)