Recruiting

FRAME Intervention

Sponsor:

Bruyère Health Research Institute.

Code:

NCT07313657

Conditions

Heart Failure

Mental Health

Stress

Anxiety

Depression

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Heart Failure and Mental Health Intervention (FRAME)

Study Details

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.

Conditions

Heart Failure

Mental Health

Stress

Anxiety

Depression

Study ID

NCT07313657

Start date

Sep 26, 2025

Status verified date

Feb, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

7300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: FRAME Intervention

Every participant who completed the intake survey for baseline data collection will receive the FRAME intervention via email in April 2026.

Interventions

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 outcome measure

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

Central Contacts and Locations

Central contacts

Krystal Kehoe MacLeod, PhD

613-862-4314kmacleod@bruyere.org

Locations

Seaway Valley Community Health Centre (Cardiac Rehab Program)

Recruiting

Cornwall, Ontario, Canada

Orleans Cardiopulmonary Clinic

Recruiting

Orléans, Ontario, Canada

Winchester Memorial Hospital

Recruiting

Winchester, Ontario, Canada

More Information

Sponsor

Bruyère Health Research Institute.

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Heart Failure and Mental Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bruyère Health Research Institute. on 2026-02-17.