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Improving Care and Mental Well-Being for Adults With Heart Failure

RecruitingNAAges 40 Years - anyAllBruyère Health Research Institute.
NCT07313657 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 inte

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📋 Eligibility rules (as published)
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
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What it tests

  • Heart Failure and Mental Health Intervention (FRAME)
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Where

9 sites
Seaway Valley Community Health Centre (Cardiac Rehab Program)
Cornwall, Canada
Centre de Santé Communautaire de l'Estrie
Limoges, Canada
Orleans Cardiopulmonary Clinic
Orléans, Canada
Bruyère Health Research Institute
Ottawa, Canada
Byward Family Health Team
Ottawa, Canada
Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic
Ottawa, Canada
Ste-Anne Medical Clinic
Ottawa, Canada
University of Ottawa Heart Institute
Ottawa, Canada

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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