Improving Care and Mental Well-Being for Adults With Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorBruyère Health Research Institute.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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"
Disqualifiers
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.
Providers that are not involved in the care of heart failure patients
Trial design
Design model
Single group
Treatments tested in this trial
Heart Failure and Mental Health Intervention (FRAME)
Other interventionFoundation, 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.
Treatment groups
7,300 Participants
are divided into 1 treatment groupGroup A: FRAME InterventionOther 1 intervention
Trial outcomes
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.
Time frame
Baseline, and up to 6 months following interventionSecondary outcomes
1
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.
Time frame
Baseline, and up to 6 months following intervention2
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.
Time frame
Baseline, and up to 6 months following interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bruyère Health Research Institute.
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov