Clinical trial NCT03479424: Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
Official title: Home Outpatient Monitoring and Engagement to Predict HF Exacerbation (HOME PREDICT-HF)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: hospitalization
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: MYIA Labs, Inc.
First posted: 2018-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 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: 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:

1. Outpatient and cared for by a PINNACLE Registry practice
2. Age ≥ 18 years old
3. Has a diagnosis of HF in the PINNACLE Registry/Medical Record
4. Seen by PINNACLE practice within the last 12 months
5. Has an LVEF ≤40% on their last data entry (within 1 year) in the PINNACLE Registry
6. NYHA Class II-IV by self-report
7. Has had a hospitalization for HF in the previous 6 months by self-report
8. Owns an Android or iOS smartphone, within Verizon cellular coverage zone in order to allow for data submission.
9. Sleep in the same bed at least 5 days per week
10. Willingness to complete the required surveys, measurements and study activities.

Exclusion Criteria:

1. Home oxygen use
2. Current or planned ventricular assist device
3. Previously or currently on a heart transplant list
4. Chronic dialysis
5. A diagnosis of any cancer and undergoing active treatment
6. In hospice or palliative care
7. Planned surgery/procedure in the next 3 months
8. Planned extended time away from home (\>2 weeks) in the next 3 months
9. Living in a skilled nursing facility or other chronic care facility
10. Pregnancy or planned pregnancy in the next 3 months
11. Inability or unwillingness to consent and/or follow requirements of the study

Primary outcomes:
measure: Heart Failure Hospitalization/ ED Visit
timeFrame: 90 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jeff Olgin, MD
role: PRINCIPAL_INVESTIGATOR
References: