Home Outpatient Monitoring and Engagement to Predict HF Exacerbation (Home Predict)

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Observational

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94105
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training Set; n = 333	Other: Observational; The MYIA in-home suite of devices.; Other Names: The MYIA in-home suite of devices.
Validation Set; n = 167	Other: Observational; The MYIA in-home suite of devices.; Other Names: The MYIA in-home suite of devices.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: MYIA Labs, Inc.
• Investigators: Principal Investigator: Jeff Olgin, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: hospitalization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 18-24445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No