Heart FailureNCT07313657
Improving Care and Mental Well-Being for Adults With Heart Failure
A study testing Heart Failure and Mental Health Intervention (FRAME) in people with Heart Failure and Mental Health, run by Bruyère Health Research Institute. at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure, Mental Health, Stress
- What is being tested?
- Heart Failure and Mental Health Intervention (FRAME)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,300 participants
- Where
- 9 sitesCanada
- Study dates
- 26 Sep 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
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- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Canada9 sites, 5 recruiting
- Recruiting
Seaway Valley Community Health Centre (Cardiac Rehab Program)
Cornwall, Ontario
- Active, not recruiting
Centre de Santé Communautaire de l'Estrie
Limoges, Ontario
- Recruiting
Orleans Cardiopulmonary Clinic
Orléans, Ontario
- Not yet recruiting
Bruyère Health Research Institute
Ottawa, Ontario, K1N 5C8
Krystal Kehoe MacLeod Principal Investigator, 613-862-4314, kmacleod@bruyere.org
Krystal Kehoe MacLeod Principal Investigator
- Not yet recruiting
Byward Family Health Team
Ottawa, Ontario
- Active, not recruiting
Montfort Hospital, and associated Aline-Chrétien Rehabilitation Clinic
Ottawa, Ontario
- Active, not recruiting
Ste-Anne Medical Clinic
Ottawa, Ontario
- Active, not recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Recruiting
Winchester Memorial Hospital
Winchester, Ontario
About this study
Official title: Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention
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
- Being tested
- Heart Failure and Mental Health Intervention (FRAME)
- Keywords
- Heart Failure and Mental Health
- Medical subject headings
- Heart Failure, Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| FRAME Intervention | Other | Every participant who completed the intake survey for baseline data collection will receive the FRAME intervention via email in April 2026. Receives: Other: Heart Failure and Mental Health Intervention (FRAME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, and up to 6 months following intervention
Secondary outcomes (2)
Engagement in Health Seeking Behaviours
This outcome evaluates whether participants (patients) report accessing mental health-related support, following the FRAME intervention. Supports may include formal resources (e.g., referrals to psychological services), informal or community-based support (e.g., peer groups, faith-based programs), and self-management strategies (e.g., mindfulness, exercise, online tools). This outcome will be measured in pre-post intervention surveys with the participants. The question will ask if, in the past 6 months, they have used community-based supports or if, in the past 6 months, they have used self-management strategies. Below these questions, there will be a list of the supports/strategies, and beside them will be checkboxes with the frequency of access. The options for this will be N/A, never, once, 2-3 times, every month and weekly or more. Change in response from pre-intervention to post-intervention will be assessed.
Measured: Baseline, and up to 6 months following intervention
Confidence in Engaging in Mental Health Conversations and Knowledge of Mental Health
This outcome assesses perceived knowledge of the interconnection between mental health and heart failure through self-reported confidence in initiating mental health discussions. This outcome will be assessed through pre- and post-intervention surveys. The question assessing perceived knowledge of mental health will be about whether they know where to find information/support about mental health in their community. The question assessing confidence in engaging in mental health conversations will ask if they feel confident bringing up my mental health with a healthcare provider in a medical setting. Both questions will have checkbox options from strongly disagree to strongly agree, where a change in responses will be assessed from pre-intervention to post-intervention.
Measured: Baseline, and up to 6 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start26 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313657
- Sponsor's protocol ID
- M16-25-028
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We currently have no motivation for sharing IPD, but if our data becomes helpful for the conduction of a follow-up project, IPD may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention
- ClinicalTrials.gov ID
- NCT07313657
- Acronym / sponsor ID
- M16-25-028
- Conditions
- Heart Failure, Mental Health, Stress, Anxiety, Depression
- Keywords
- Heart Failure and Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,300 participants (estimated)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FRAME Intervention | Other | Other: Heart Failure and Mental Health Intervention (FRAME)Every participant who completed the intake survey for baseline data collection will receive the FRAME intervention via email in April 2026. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 :
- 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 who support adult(s) with heart failure.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | FRAME Intervention |
Primary outcome
Frequency of Mental Health Conversations
Time frame: Baseline, and up to 6 months following intervention
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.
2 secondary outcomes
Engagement in Health Seeking Behaviours
Time frame: Baseline, and up to 6 months following intervention
Confidence in Engaging in Mental Health Conversations and Knowledge of Mental Health
Time frame: Baseline, and up to 6 months following intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Project Background and Information from the Research Team conducting this studyLink provided by the sponsor.
- Project Background and Information from the Brain-Heart Interconnectome at the University of OttawaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We currently have no motivation for sharing IPD, but if our data becomes helpful for the conduction of a follow-up project, IPD may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Failure and Mental Health Intervention (FRAME) in people with Heart Failure and Mental Health, run by Bruyère Health Research Institute. at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krystal Kehoe MacLeod, PhD (613-862-4314, kmacleod@bruyere.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Mental Health Conversations (time frame: Baseline, and up to 6 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.