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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorBruyère Health Research Institute.

About this trial

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.

Eligibility criteria

Qualifiers

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"

Disqualifiers

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.

Providers that are not involved in the care of heart failure patients

Trial design

Treatments tested in this trial

  • Heart Failure and Mental Health Intervention (FRAME)

Treatment groups

7,300 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bruyère Health Research Institute.

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator