NCT07313657 Improving Care and Mental Well-Being for Adults With Heart Failure
| NCT ID | NCT07313657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bruyère Health Research Institute. |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,300 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 7,300 participants in total. It began in 2025-09-26 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07313657 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07313657 currently recruiting?
Yes, NCT07313657 is actively recruiting participants. Contact the research team at kmacleod@bruyere.org for enrollment information.
Where is the NCT07313657 trial being conducted?
This trial is being conducted at Cornwall, Canada, Limoges, Canada, Orléans, Canada, Ottawa, Canada and 5 additional locations.
Who is sponsoring the NCT07313657 clinical trial?
NCT07313657 is sponsored by Bruyère Health Research Institute.. The trial plans to enroll 7,300 participants.
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