Better heart 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
This pilot will try the FRAME program to add mental-health awareness and support into heart-failure care for adults with or at risk of heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7300 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Bruyère Health Research Institute. Academic / other |
| Locations | 9 sites (Cornwall, Ontario and 8 other locations) |
| Trial ID | NCT07313657 on ClinicalTrials.gov |
What this trial studies
The FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, clinicians, health-system decisionmakers, and patient partners to integrate mental-health support into cardiac care. The pilot implements FRAME at team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments across two Ontario health regions. Using a pretest–posttest hybrid type 1 intervention design, the study collects implementation process indicators and patient-focused outcomes via surveys and optional interviews. Findings will inform feasibility, implementation barriers, and refinements needed before a larger effectiveness trial.
Who should consider this trial
Good fit: Adults with a documented or self-reported diagnosis of heart failure or at risk for heart failure (including those on common heart-failure medications) who receive care at participating Ontario pilot sites or who access the project website and can provide consent are ideal candidates.
Not a fit: People who do not receive care at the participating sites, who cannot provide contact information or informed consent, or who require specialized psychiatric treatment are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, integrating FRAME could provide better mental-health support for people with heart failure, reducing stress, anxiety, and depression and improving daily functioning.
How similar studies have performed: Integrating mental-health support into cardiac care has shown promise in prior work, but the specific co-designed FRAME intervention is new and needs pilot testing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cornwall, Ontario and 8 other locations
- Seaway Valley Community Health Centre (Cardiac Rehab Program) — Cornwall, Ontario, Canada (Recruiting)
- Centre de Santé Communautaire de l'Estrie — Limoges, Ontario, Canada (Active_not_recruiting)
- Orleans Cardiopulmonary Clinic — Orléans, Ontario, Canada (Recruiting)
- Bruyère Health Research Institute — Ottawa, Ontario, Canada (Not_yet_recruiting)
- Byward Family Health Team — Ottawa, Ontario, Canada (Not_yet_recruiting)
- Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic — Ottawa, Ontario, Canada (Active_not_recruiting)
- Ste-Anne Medical Clinic — Ottawa, Ontario, Canada (Active_not_recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Active_not_recruiting)
- Winchester Memorial Hospital — Winchester, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Krystal Kehoe MacLeod, PhD
- Email: kmacleod@bruyere.org
- Phone: 613-862-4314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.