Testing Heart Failure and Mental Health for heart failure
Official title: Improving Care and Mental Well-Being for Adults With Heart Failure
Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention
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.
Canadian Sites (9)
Seaway Valley Community Health Centre (Cardiac Rehab Program)
Cornwall, Ontario, Canada
Centre de Santé Communautaire de l'Estrie
Limoges, Ontario, Canada
Orleans Cardiopulmonary Clinic
Orléans, Ontario, Canada
Bruyère Health Research Institute
Ottawa, Ontario, Canada
Byward Family Health Team
Ottawa, Ontario, Canada
Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic
Ottawa, Ontario, Canada
Ste-Anne Medical Clinic
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Winchester Memorial Hospital
Winchester, Ontario, Canada
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and name, email address and phone number for follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → contact (for survey and interview)
- +Caregivers (Optional interviews):
- +Caregivers who support adult(s) with heart failure.
Exclusion
- −Inability to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is looking at how care is delivered and organised, rather than at a treatment itself.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Heart Failure and Mental Health Intervention (FRAME).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 7,300 people.
The study is currently expected to finish around November 2026.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, and up to 6 months following intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Frequency of Mental Health Conversations — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, and up to 6 months following intervention.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07313657 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, and up to 6 months following intervention.
The study as a whole is currently expected to finish around 2026-11-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 7,300 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Cornwall, Ontario, Canada; Limoges, Ontario, Canada; Orléans, Ontario, Canada; Ottawa, Ontario, Canada; Winchester, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.