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

Official title

Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention

Overview

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 include

Primary outcome measures

• Frequency of Mental Health Conversations [Time frame: Baseline, and up to 6 months following intervention]

Secondary outcome measures (2)

• Engagement in Health Seeking Behaviours [Time frame: Baseline, and up to 6 months following intervention]
• Confidence in Engaging in Mental Health Conversations and Knowledge of Mental Health [Time frame: Baseline, and up to 6 months following intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Canada · 9 centers

• Seaway Valley Community Health Centre (Cardiac Rehab Program) — Cornwall
• Centre de Santé Communautaire de l'Estrie — Limoges
• Orleans Cardiopulmonary Clinic — Orléans
• Bruyère Health Research Institute — Ottawa
• Byward Family Health Team — Ottawa
• Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic — Ottawa
• Ste-Anne Medical Clinic — Ottawa
• University of Ottawa Heart Institute — Ottawa
• … and 1 more center

Identifiers

NCT: NCT07313657 · M16-25-028

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗