Better heart care and mental well-being for adults with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Seaway Valley Community Health Centre (Cardiac Rehab Program)
  Cornwall, Ontario, Canada Recruiting
• Orleans Cardiopulmonary Clinic
  Orléans, Ontario, Canada Recruiting
• Winchester Memorial Hospital
  Winchester, Ontario, Canada Recruiting
• Centre de Santé Communautaire de l'Estrie
  Limoges, Ontario, Canada Active not recruiting
• Bruyère Health Research Institute
  Ottawa, Ontario, Canada Not yet recruiting
• Byward Family Health Team
  Ottawa, Ontario, Canada Not yet recruiting

Study contacts

• Study coordinator: Krystal Kehoe MacLeod, PhD
• Email: kmacleod@bruyere.org
• Phone: 613-862-4314

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.