FRAME for Heart Failure

Recruiting at 8 trial locations

Overseen By Krystal Kehoe MacLeod, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bruyère Health Research Institute.

Must be taking: ARNI, ACEi, ARBs, Beta-blockers

Disqualifiers: Cognitive impairment, No internet access

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

7300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called the Heart Failure and Mental Health Intervention (FRAME) to assist individuals with heart failure who also experience mental health challenges such as stress, depression, or anxiety. The researchers aim to determine if combining heart and mental health care can enhance overall well-being. Conducted at specific clinics in Ontario, Canada, participants will receive resources via email. This trial suits those with heart conditions or those taking certain heart medications who can access the internet. The study's results will inform whether this approach can be more widely implemented in the future. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve treatment options for heart and mental health care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it includes patients who are already on certain heart failure medications, so you might not need to stop them.

What prior data suggests that the FRAME intervention is safe for heart failure patients?

Research has shown that mental health treatments can be safe for people with heart failure. Previous studies have linked therapies like talk therapy and mental health medications to better outcomes for those with heart issues. These treatments often lead to fewer hospital visits and improved overall health.

However, results can sometimes be mixed. Some studies show positive effects, while others report different findings. While many people handle these treatments well, individual experiences can vary.

Mental health care remains crucial for improving the lives of heart failure patients. The FRAME intervention combines mental health support with heart care. This approach has been carefully developed to be both safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The FRAME intervention is unique because it combines heart failure management with mental health support, delivered conveniently via email. Unlike traditional treatments that often focus solely on physical symptoms using medications like ACE inhibitors or beta-blockers, FRAME aims to address the emotional well-being of patients, which can significantly impact overall health outcomes. Researchers are excited about this approach because it could offer a more holistic treatment, potentially improving both mental and physical health in a seamless, accessible way.

What evidence suggests that the FRAME intervention is effective for heart failure patients?

Studies have shown that people with heart failure often face mental health challenges like stress, depression, and anxiety. Research indicates that addressing these mental health issues can improve overall health for heart failure patients. For example, one study found that including mental health support in heart care improved both mental well-being and heart health. Another study suggested that managing mental health alongside heart failure led to a better quality of life and fewer symptoms for patients. This trial will offer the FRAME intervention, which combines heart and mental health care, to all participants, aiming to demonstrate its potential benefits for those with heart failure. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who are on specific heart medications like ARNI, beta-blockers, MRAs, SGLT2 inhibitors, ARBs or ACEi. Participants must be receiving care at certain sites in Ontario or have accessed the FRAME tool online and be willing to provide contact details for follow-up.

Inclusion Criteria

I am taking medication that ends in 'pril'.

I am getting care at a site participating in the study or found the study online.

I am willing to give my consent and contact details for follow-up.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the FRAME intervention via email, which integrates mental health support into heart failure care

6 months

Baseline survey and post-intervention survey

Follow-up

Participants are monitored for changes in mental health engagement and conversations post-intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Heart Failure and Mental Health Intervention (FRAME)

Trial Overview

The study tests the FRAME intervention designed to improve mental health support within cardiac care. It involves team-based clinics and emergency departments in a pretest-posttest design to measure its feasibility and impact on patient well-being through surveys and interviews.

How Is the Trial Designed?

Group I: FRAME Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Bruyère Health Research Institute.

Lead Sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07313657

Improving Care and Mental Well-Being for Adults With ...

Patients at risk of heart failure (e.g., irregular heartbeat, coronary artery disease, a past heart attack, high blood pressure that is being ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12086933/

Access to mental health services for people living with heart ...

Impact of Mental Health Treatment on Outcomes in Patients With Heart Failure and Ischemic Heart Disease. JAHA . 2024;13 doi: 10.1161/JAHA ...

3.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/57/NCT07313657/Prot_SAP_000.pdf

Integrating Mental Health into Heart Failure Care

This will be self-reported by patients with heart failure before and after the exposure to the FRAME intervention. This will be measured by a self-reported ...

4.

jmir.org

jmir.org/2025/1/e57368

Psychological eHealth Interventions for Patients With ...

... health outcomes of patients with coronary heart disease: A randomised controlled trial. ... The intriguing relationship between coronary heart ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8026548/

Psychological Stress in Heart Failure: A Potentially ...

Emerging evidence suggests that heart failure patients who experience higher levels of stress may have a more burdensome disease course, with diminished quality ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.123.031117

Impact of Mental Health Treatment on Outcomes in Patients ...

There is conflicting evidence as to the impact of mental health treatment on outcomes in patients with heart disease. The aim of this study ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S073510970601905X

Depression in Heart Failure: A Meta-Analytic Review of ...

This article describes a meta-analysis of published associations between depression and heart failure (HF) in regard to 3 questions.

8.

medrxiv.org

medrxiv.org/content/10.1101/2023.05.23.23290426v1.full-text

Association of Mental Health Treatment on Outcomes in ...

The aim of this study was to use a public data base to examine the impact of psychotherapy or psychopharmacologic treatments on adverse outcomes ...