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Home Outpatient Monitoring and Engagement to Predict HF Exacerbation

NCT ID: NCT03479424

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-08

Study Completion Date

2019-03-01

Brief Summary

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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

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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.

Conditions

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Heart Failure With Reduced Ejection Fraction

Keywords

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hospitalization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training Set

n = 333

Observational

Intervention Type OTHER

The MYIA in-home suite of devices.

Validation Set

n = 167

Observational

Intervention Type OTHER

The MYIA in-home suite of devices.

Interventions

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Observational

The MYIA in-home suite of devices.

Intervention Type OTHER

Other Intervention Names

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The MYIA in-home suite of devices.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MYIA Labs, Inc.

UNKNOWN

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Olgin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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18-24445

Identifier Type: -

Identifier Source: org_study_id