Recruiting

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

ClinicalTrials.gov IDNCT07313657

PhaseNA

Enrollment7300

SponsorBruyère Health Research Institute.

Age40 Years

SexALL

I'm interested View official listing

Conditions studied

Heart Failure, Mental Health, Stress, Anxiety, Depression

About this study

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.

Interventions

Other: Heart Failure and Mental Health Intervention (FRAME) — Foundation, Recognition, Awareness, Management and Engagement (FRAME) is a multi-component, co-designed web tool created in collaboration with patient partners, caregivers, healthcare providers, and Archipel and Great River Ontario Health Teams. It is designed to improve recognition, awareness, management and support for mental health in patients with heart failure. There are three different versions: one for healthcare providers, one for caregivers and one for patients. The intervention includes educational material about heart failure and mental health, conversational support to help facilitate discussions about mental health, self-management activity maps (e.g., tips about nutrition and exercise), asset maps (i.e., displaying available resources), and the provider-facing discussion tool to help initiate conversations about mental health and guide referrals or supports. FRAME was developed through a co-design process informed by the lived experiences of community partners.

Primary outcomes

Frequency of Mental Health Conversations (Baseline, and up to 6 months following intervention)

Eligibility information

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

Study locations

Seaway Valley Community Health Centre (Cardiac Rehab Program), Cornwall, Ontario Canada
Centre de Santé Communautaire de l'Estrie, Limoges, Ontario Canada
Orleans Cardiopulmonary Clinic, Orléans, Ontario Canada
Bruyère Health Research Institute, Ottawa, Ontario K1N 5C8 Canada
Byward Family Health Team, Ottawa, Ontario Canada
Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic, Ottawa, Ontario Canada
Ste-Anne Medical Clinic, Ottawa, Ontario Canada
University of Ottawa Heart Institute, Ottawa, Ontario Canada
Winchester Memorial Hospital, Winchester, Ontario Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.