Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7,300
- 试验地点
- 9
- 主要终点
- Frequency of Mental Health Conversations
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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.
排除标准
- •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
研究组 & 干预措施
FRAME Intervention
Every participant who completed the intake survey for baseline data collection will receive the FRAME intervention via email in April 2026.
干预措施: Heart Failure and Mental Health Intervention (FRAME) (Other)
结局指标
主要结局
Frequency of Mental Health Conversations
时间窗: 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.
次要结局
- Engagement in Health Seeking Behaviours(Baseline, and up to 6 months following intervention)
- Confidence in Engaging in Mental Health Conversations and Knowledge of Mental Health(Baseline, and up to 6 months following intervention)