Heart Failure Clinical Trial
Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
San Francisco California, 94105, United States
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