Status:
TERMINATED
Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
MYIA Labs, Inc.
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Brief 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 us...
Detailed 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 ord...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03479424
Start Date
October 8 2018
End Date
March 1 2019
Last Update
December 20 2019
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94105