RecruitingNAINTERVENTIONAL

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

Heart failure can be a long-term condition that often affects a person's mental health, leading to stress, worry, or sadness. This study introduces something called FRAME, a new program designed to help healthcare teams better understand and support the mental well-being of people living with heart failure. We want to see if FRAME can be successfully used in different clinics, like family doctor's offices, heart clinics, and even emergency departments, in parts of Canada. By checking how well it works and how patients feel, this study will help us understand if FRAME could be used more widely to improve care for people with heart failure and their mental health.

At a glance

Status

Recruiting

Phase

Sponsor

Bruyère Health Research Institute.

Enrolment target

7,300

Start

26 Sep 2025

Estimated completion

30 Nov 2026

Heart Failure Mental Health Stress Anxiety Depression

What is this study about?

Living with heart failure can be really challenging, not just physically but also emotionally. Many people with this condition also experience things like stress, anxiety, or depression. While we know mental health is important, support for these feelings isn't always fully included in standard heart care. This often means people don't get all the help they need.

That's where the FRAME program comes in. FRAME stands for 'Foundation, Recognition, Awareness, Management, Engagement'. It's a new approach that was designed with input from patients, doctors, and other experts. The idea is to make it easier for healthcare teams to spot mental health issues in people with heart failure and offer the right support. This study is a small, early test to see if the FRAME program can actually be put into practice smoothly in real-world clinics and hospitals.

The main goal of this pilot study is to see how well the FRAME program works in a few different healthcare settings. Researchers are looking at things like how easy it is for staff to use and how patients feel about the support they receive. The results from this study will help us understand if FRAME is a good idea and how it could be improved. This information will then be used to plan bigger studies in the future, with the hope of making mental health support a regular part of heart failure care for everyone.

Key takeaways

Heart failure can affect mental health, causing stress, anxiety, or depression.
The FRAME program aims to integrate mental health support into heart care.
This study tests if FRAME can be successfully used in different clinics.
Participant feedback (surveys, interviews) is vital for improving heart care.
The goal is better mental well-being for people with heart failure.
Your standard medical care for heart failure will not be changed by this study.

Who may be eligible?

First, for patients who might take part, you would generally need to have heart failure, or be at risk of developing it. This could mean you have conditions like an irregular heartbeat, high blood pressure that's being treated, or have had a heart attack in the past. You might also be eligible if you're taking certain heart medications, such as those often called "prils," "sartans," "lols," or "flozins."

To be considered, you also need to be receiving care at one of the clinics involved in this study, or have found the study resources online. It's important that you're willing and able to understand what the study involves and agree to take part, and be happy to share your contact details for follow-up.

Some reasons you might not be able to join include if you're unable to give informed consent, for example, due to memory problems or if there's a language barrier where translation isn't available. Also, if you don't have internet access, you wouldn't be able to use the online parts of the program. Caregivers who support adults with heart failure can also take part in optional interviews.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have heart failure, or am I at risk of developing it?
Am I taking certain heart medications (e.g., those ending in "pril," "sartan," "lol," or "flozin")?
Do I receive care at a participating clinic in Ontario, Canada, or can I access their website?
Am I able to understand the study information and give my agreement to take part?
Do I have internet access to use any online tools involved?
Am I willing to share my contact details for follow-up?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement would primarily be through surveys and possibly some interviews. You would be asked to fill out surveys to share your experiences and how you're feeling before and after using the FRAME mental health support tool. Some participants might also be invited for semi-structured interviews to talk more in-depth about their experiences. There are no new medications or extra clinic visits specifically for this study beyond your usual care. The total duration of your participation would depend on how long the surveys and interviews take, typically spread over a period to see the impact of the FRAME intervention.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving dedicated support for your mental well-being, which is often an overlooked aspect of heart failure care. It could also give you a chance to share your experiences, helping to shape better support for others in the future. As this is a pilot study, there are no known major physical risks; however, discussing your mental health can sometimes bring up difficult feelings. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (9)

Seaway Valley Community Health Centre (Cardiac Rehab Program)
Verified postcode
Cornwall, Canada· Recruiting
Centre de Santé Communautaire de l'Estrie
Verified postcode
Limoges, Canada· Active not recruiting
Orleans Cardiopulmonary Clinic
Verified postcode
Orléans, Canada· Recruiting
Bruyère Health Research Institute
Verified postcode
Ottawa, Canada· Not yet recruiting
Byward Family Health Team
Verified postcode
Ottawa, Canada· Not yet recruiting
Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic
Verified postcode
Ottawa, Canada· Active not recruiting
Ste-Anne Medical Clinic
Verified postcode
Ottawa, Canada· Active not recruiting
University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada· Active not recruiting
Winchester Memorial Hospital
Verified postcode
Winchester, Canada· Recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as well as it should, leading to symptoms like breathlessness or tiredness. It doesn't mean your heart has stopped working.

What is the FRAME program?

FRAME is a new program designed to help healthcare teams better recognise and support the mental health needs, like stress or anxiety, of people living with heart failure.

Will this study change my heart failure treatment?

No, this study focuses on mental health support and aims to fit alongside your current heart failure treatment. It won't change your medical management.

How long will I need to be involved?

Your involvement would mainly include completing surveys and potentially an interview, spread over a period to see the effects of the FRAME program. The exact duration would be explained in more detail if you're invited to participate.

Do I have to live in Canada to take part?

Yes, this specific pilot study is taking place in certain clinics within two regions in Ontario, Canada. Only people receiving care there, or through a specific related website, can participate.

How to find out more

Krystal Kehoe MacLeod, PhD

kmacleod@bruyere.org 613-862-4314 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.