Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure: The ENGAGE-HF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Medication optimization score at 90 days
研究概览
简要总结
The ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. Helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure.
In this study, the investigators aim to evaluate whether the ENGAGE-HF mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (GDMT) and quality of life.
An optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of heart failure
- •Last left ventricular ejection fraction within 2 years < 50% based on echocardiogram, MRI, CT, or nuclear perfusion and, if no ejection fraction documented, then clinical documentation of heart failure with reduced ejection fraction
- •Currently admitted with upcoming discharge or discharged from hospital within the prior 4 weeks
- •At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or at < 50% of target dose at time of enrollment
排除标准
- •Receives dialysis
- •Inotropic therapy after hospitalization
- •History of a prior solid organ transplant or actively listed on heart transplant waiting list
- •History of left ventricular assist device implantation
- •Cardiac amyloidosis
- •Currently pregnant or intends to become pregnant during the study period
- •Life expectancy estimated less than 6 months related to cardiac or non-cardiac comorbidities as per investigator's judgment
- •Actively enrolled in hospice or comfort care
- •Currently participating in an investigational device or drug study or having participated in such a study 30 days prior to screening
- •Subject without a compatible smartphone
- •Subject not proficient with written and spoken English
- •Any other disorder or condition that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •Participant has diminished decision-making capacity
- •Admitted to or planned discharge to a skilled nursing facility or rehabilitation facility (acute or subacute)
研究组 & 干预措施
Intervention
The ENGAGE-HF intervention is a combination of a patient-facing mobile application that is integrated with a remote blood pressure cuff and scale along with a clinician-facing dashboard. The mobile application helps complete standard ambulatory monitoring recommended by heart failure clinicians. Simultaneously, the application includes visualizations of that data and education for patients that is intended to promote patient engagement and patient understanding of heart failure care. The information is then made available to treating clinicians via a PDF summary to facilitate outpatient management of the patient by the clinician. There are also a select set of notifications triggered by the ENGAGE-HF platform that will be transmitted to the treating clinician.
干预措施: ENGAGE-HF Mobile Application (Device)
Control Group
Participants randomized to the control group will receive usual heart failure care.
结局指标
主要结局
Medication optimization score at 90 days
时间窗: From enrollment to the end of participation at 90 days
The primary outcome will be the difference in the medication optimization score at 90 days between the intervention and control group. The MOS is a percent between 0 (least optimized) and 100 (most optimized), which represents the extent of medication optimization that needs to be performed. Inputs for the score include medications, vital signs, and laboratory values, and thus, the score accounts for contraindications to medical therapy titration. The score has been shown to correlate with clinical outcomes in two large randomized controlled trials.
次要结局
- Kansas City Cardiomyopathy Questionnaire (KCCQ-23)(Baseline and at 90 days)
研究者
Michael Dorsch
Associate Professor of Pharmacy
University of Michigan