NCT07313657Recruiting
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
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 7300 (estimated)
- First submitted
- 23 Sept 2025
- Start date
- 26 Sept 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Bruyère Health Research Institute.
- Diseases
- Heart failure
- NCT number
- NCT07313657
What you commit to
- Study type: Interventional
- Planned participants: 7300
- From 26 Sept 2025 to the primary completion date, 30 Nov 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to provide informed consent (e.g., due to cognitive impairment or language barriers without translated support)
- Providers that are not involved in the care of heart failure patients
Other
- Participants who do not have access to the internet will not be able to use the web-tool.
- For Healthcare Providers
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seaway Valley Community Health Centre (Cardiac Rehab Program) Coordinator of this site? Confirm its status | Cornwall | Canada | Recruiting |
| Centre de Santé Communautaire de l'Estrie Coordinator of this site? Confirm its status | Limoges | Canada | Active, not recruiting |
| Orleans Cardiopulmonary Clinic Coordinator of this site? Confirm its status | Orléans | Canada | Recruiting |
| Byward Family Health Team Coordinator of this site? Confirm its status | Ottawa | Canada | Not yet recruiting |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Active, not recruiting |
| Bruyère Health Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Not yet recruiting |
| Ste-Anne Medical Clinic Coordinator of this site? Confirm its status | Ottawa | Canada | Active, not recruiting |
| Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic Coordinator of this site? Confirm its status | Ottawa | Canada | Active, not recruiting |
| Winchester Memorial Hospital Coordinator of this site? Confirm its status | Winchester | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.