Actively Recruiting
Improving Care and Mental Well-Being for Adults With Heart Failure
Led by Bruyère Health Research Institute. · Updated on 2026-02-17
7300
Participants Needed
9
Research Sites
61 weeks
Total Duration
On this page
Sponsors
B
Bruyère Health Research Institute.
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Care and Mental Well-Being for Adults With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 years or older
- Patients diagnosed with or at risk of heart failure (such as those with irregular heartbeat, coronary artery disease, past heart attack, treated high blood pressure, or cardiomyopathy)
- Patients currently taking medications including ARNI (sacubitril-valsartan), ACE inhibitors ("prils"), ARBs ("sartans"), beta-blockers ("lols"), MRAs, or SGLT2 inhibitors ("flozins")
- Receiving care at one of the participating pilot test sites or who have accessed the tool website
- Willing and able to provide informed consent and contact information for follow-up
- Caregivers who support adults with heart failure may participate in optional interviews
You will not qualify if you...
- Unable to provide informed consent due to cognitive impairment or language barriers without translation support
- No access to the internet to use the web-based tool
- Healthcare providers not involved in caring for heart failure patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Seaway Valley Community Health Centre (Cardiac Rehab Program)
Cornwall, Ontario, Canada
Actively Recruiting
2
Centre de Santé Communautaire de l'Estrie
Limoges, Ontario, Canada
Active, Not Recruiting
3
Orleans Cardiopulmonary Clinic
Orléans, Ontario, Canada
Actively Recruiting
4
Bruyère Health Research Institute
Ottawa, Ontario, Canada, K1N 5C8
Not Yet Recruiting
5
Byward Family Health Team
Ottawa, Ontario, Canada
Not Yet Recruiting
6
Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic
Ottawa, Ontario, Canada
Active, Not Recruiting
7
Ste-Anne Medical Clinic
Ottawa, Ontario, Canada
Active, Not Recruiting
8
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Active, Not Recruiting
9
Winchester Memorial Hospital
Winchester, Ontario, Canada
Actively Recruiting
Research Team
K
Krystal Kehoe MacLeod, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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