Home Outpatient Monitoring and Engagement to Predict HF Exacerbation

NCT03479424 | Terminated

• 1 other identifier: 18-24445
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

hospitalization

Outcome Measures

Primary Outcomes (1)

• Heart Failure Hospitalization/ ED Visit

  Ninety-day heart failure hospitalization/emergency department visit for heart failure.

  90 day

Study Arms (2)

Training Set

n = 333

Other: Observational

Validation Set

n = 167

Other: Observational

Interventions

Observational OTHER

The MYIA in-home suite of devices.

Also known as: The MYIA in-home suite of devices.

Training Set; Validation Set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• MYIA Labs, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94105, United States

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Jeff Olgin, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: October 8, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)