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

NCT07313657 | Recruiting

• 1 other identifier: M16-25-028
• Study Type: interventional
• Target: 7,300
• Locations: 1 country
• Sites: 9

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

Keywords

Heart Failure and Mental Health

Outcome Measures

Primary Outcomes (1)

• Frequency of Mental Health Conversations

  This outcome measures whether patients with heart failure report having a discussion about mental health with their healthcare provider or loved ones after being introduced to FRAME. This will be measured by changes in response to two questions in a survey given to participants pre- and post-intervention. These questions will ask if in the past 6 months, they have discussed mental health with a healthcare provider or if in the past 6 months, they have discussed mental health with their loved ones. The responses will include strongly disagree, disagree, neutral, agree and strongly agree. The intervention will be rolled out, after which they can respond to the post-intervention survey anytime until the study closes. Change in response from pre-intervention to post-intervention will be assessed.

  Baseline, and up to 6 months following intervention

Secondary Outcomes (2)

• Engagement in Health Seeking Behaviours

  Baseline, and up to 6 months following intervention

• Confidence in Engaging in Mental Health Conversations and Knowledge of Mental Health

  Baseline, and up to 6 months following intervention

Study Arms (1)

FRAME Intervention

OTHER

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

Other: Heart Failure and Mental Health Intervention (FRAME)

Interventions

Heart Failure and Mental Health Intervention (FRAME) OTHER

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.

FRAME Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bruyère Health Research Institute.: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (9)

Seaway Valley Community Health Centre (Cardiac Rehab Program)

Cornwall, Ontario, Canada

RECRUITING

Centre de Santé Communautaire de l'Estrie

Limoges, Ontario, Canada

ACTIVE NOT RECRUITING

Orleans Cardiopulmonary Clinic

Orléans, Ontario, Canada

RECRUITING

Bruyère Health Research Institute

Ottawa, Ontario, K1N 5C8, Canada

NOT YET RECRUITING

Byward Family Health Team

Ottawa, Ontario, Canada

NOT YET RECRUITING

Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic

Ottawa, Ontario, Canada

ACTIVE NOT RECRUITING

Ste-Anne Medical Clinic

Ottawa, Ontario, Canada

ACTIVE NOT RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

ACTIVE NOT RECRUITING

Winchester Memorial Hospital

Winchester, Ontario, Canada

RECRUITING

Related Links

• Project Background and Information from the Research Team conducting this study
• Project Background and Information from the Brain-Heart Interconnectome at the University of Ottawa

MeSH Terms

Conditions

Heart Failure; Psychological Well-Being; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms

Central Study Contacts

Krystal Kehoe MacLeod, PhD

CONTACT

613-862-4314; kmacleod@bruyere.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type 1 effectiveness- implementation design, which is well-suited to for evaluating interventions in real-world healthcare settings where both clinical outcomes and implementation processes are focus areas. This design evaluates the effectiveness of an intervention while also collecting formative data to understand it's implementation context, where we determine its feasibility, acceptability, barriers and facilitators to uptake to support future trials. The primary aim of Hybrid Type 1 would be to determine whether an intervention is effective in improving targeted outcomes. In our study, the aim of this design would be to determine whether the intervention is effective in improving our outcome measures.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: January 2, 2026
• Study Start: September 26, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CA (9)