RecruitingNot ApplicableNCT07313657

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

Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention

Sponsor

Bruyère Health Research Institute.

Enrollment

7,300 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure Depression Stress Anxiety Mental Health

Summary

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a digital tool to help people with heart failure — and those at risk for it — better understand their condition and feel more supported in managing their care. You may be eligible if (as a patient): - You have been diagnosed with heart failure, OR - You are at risk for heart failure (for example, you have an irregular heartbeat, coronary artery disease, a past heart attack, high blood pressure being treated, or a heart muscle condition) - OR you are currently taking any of the following medicines: sacubitril-valsartan, ACE inhibitors (called 'prils'), ARBs (called 'sartans'), beta-blockers (called 'lols'), aldosterone blockers, or SGLT2 inhibitors (called 'flozins') - You receive care at a participating clinic, or you found the study's online tool - You are willing to provide contact information for follow-up You may also be eligible as a caregiver if you support an adult with heart failure. You may NOT be eligible if: - You are not able to give consent (for example, due to severe memory problems or language barriers without translation support) - You do not have internet access (as the tool is web-based) - You are a healthcare provider who does not treat heart failure patients Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHeart Failure and Mental Health Intervention (FRAME)

Foundation, Recognition, Awareness, Management and Engagement (FRAME) is a multi-component, co-designed web tool created in collaboration with patient partners, caregivers, healthcare providers, and Archipel and Great River Ontario Health Teams. It is designed to improve recognition, awareness, management and support for mental health in patients with heart failure. There are three different versions: one for healthcare providers, one for caregivers and one for patients. The intervention includes educational material about heart failure and mental health, conversational support to help facilitate discussions about mental health, self-management activity maps (e.g., tips about nutrition and exercise), asset maps (i.e., displaying available resources), and the provider-facing discussion tool to help initiate conversations about mental health and guide referrals or supports. FRAME was developed through a co-design process informed by the lived experiences of community partners.