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

NCT07313657 · Bruyère Health Research Institute.
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Official title
Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention
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.
Eligibility criteria
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
Study design
Enrollment target: 7300 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-26
Estimated completion: 2026-11-30
Last updated: 2026-02-17
Interventions
Other: Heart Failure and Mental Health Intervention (FRAME)
Primary outcomes
  • Frequency of Mental Health Conversations (Baseline, and up to 6 months following intervention)
Sponsor
Bruyère Health Research Institute. · other
With: Canadian Institutes of Health Research (CIHR)
Contacts & investigators
ContactKrystal Kehoe MacLeod, PhD · contact · kmacleod@bruyere.org · 613-862-4314
All locations (9)
Seaway Valley Community Health Centre (Cardiac Rehab Program)Recruiting
Cornwall, Ontario, Canada
Centre de Santé Communautaire de l'EstrieActive Not Recruiting
Limoges, Ontario, Canada
Orleans Cardiopulmonary ClinicRecruiting
Orléans, Ontario, Canada
Bruyère Health Research InstituteNot Yet Recruiting
Ottawa, Ontario, Canada
Byward Family Health TeamNot Yet Recruiting
Ottawa, Ontario, Canada
Montfort Hospital, and associated Aline-Chrétien Rehabilitation ClinicActive Not Recruiting
Ottawa, Ontario, Canada
Ste-Anne Medical ClinicActive Not Recruiting
Ottawa, Ontario, Canada
University of Ottawa Heart InstituteActive Not Recruiting
Ottawa, Ontario, Canada
Winchester Memorial HospitalRecruiting
Winchester, Ontario, Canada
Improving Care and Mental Well-Being for Adults With Heart Failure · TrialPath