Home Outpatient Monitoring and Engagement to Predict HF Exacerbation

Study Overview
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Brief Summary
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The HOME PREDICT HF study looks at new ways to predict hospitalizations for heart failure. We will use a set of devices at home and surveys to collect information about patient's health. This study uses the Eureka app, a new study app developed by the University of California, San Francisco. The study is designed to happen remotely, using this application on a patient's smartphone, so that is as convenient as possible to participate.

Detailed Description
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HOME PREDICT HF is single center, prospective, unblinded, randomly assigned training and validation observational cohorts to develop machine learning algorithms from an in-home suite of sensors in order to predict 3-month heart failure hospitalization and/or emergency department visits. Study population includes adults presenting with a diagnosis of reduced ejection fraction (LVEF <= 40%), NYHA class II-IV) who have had a hospitalization for HF in the previous 6 months. The study objectives include (1) To collect observational data from multiple sensors, patient-reported outcomes, and medical record data to develop (train) machine-learning algorithms (2) To validate trained algorithms in a separate validation cohort (3) To collect data to inform the design of a future intervention study. The primary outcome is Ninety-day heart failure hospitalization/emergency department visit for heart failure.

Official Title
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Home Outpatient Monitoring and Engagement to Predict HF Exacerbation (HOME PREDICT-HF)

Conditions
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Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient and cared for by a PINNACLE Registry practice Age ≥ 18 years old Has a diagnosis of HF in the PINNACLE Registry/Medical Record Seen by PINNACLE practice within the last 12 months Has an LVEF ≤40% on their last data entry (within 1 year) in the PINNACLE Registry NYHA Class II-IV by self-report Has had a hospitalization for HF in the previous 6 months by self-report Owns an Android or iOS smartphone, within Verizon cellular coverage zone in order to allow for data submission. Sleep in the same bed at least 5 days per week Willingness to complete the required surveys, measurements and study activities. Exclusion Criteria: Home oxygen use Current or planned ventricular assist device Previously or currently on a heart transplant list Chronic dialysis A diagnosis of any cancer and undergoing active treatment In hospice or palliative care Planned surgery/procedure in the next 3 months Planned extended time away from home (>2 weeks) in the next 3 months Living in a skilled nursing facility or other chronic care facility Pregnancy or planned pregnancy in the next 3 months Inability or unwillingness to consent and/or follow requirements of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training Set<br>n = 333 | Other: Observational<br>* The MYIA in-home suite of devices.<br>* Other names: The MYIA in-home suite of devices.;|
| Validation Set<br>n = 167 | Other: Observational<br>* The MYIA in-home suite of devices.<br>* Other names: The MYIA in-home suite of devices.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Hospitalization/ ED Visit | Ninety-day heart failure hospitalization/emergency department visit for heart failure. | 90 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hospitalization