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TerminatedNCT03479424Home PredictUpdated Dec 20, 2019

Home Outpatient Monitoring and Engagement to Predict HF Exacerbation

An observational study in Heart Failure With Reduced Ejection Fraction, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-20.

Sponsored by University of California, San Francisco · Observational

Why this study was terminated
Slow recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction

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Keywords

  • hospitalization
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Training Set

    n = 333

    Other: Observational

  • Validation Set

    n = 167

    Other: Observational

Interventions

  • OtherObservational

    The MYIA in-home suite of devices.

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

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What researchers measure

Primary outcomes

  1. Heart Failure Hospitalization/ ED Visit

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

    Time frame: 90 day

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Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94105, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03479424
Lead sponsor
University of California, San Francisco
Collaborators
MYIA Labs, Inc.
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Oct 8, 2018
Primary completion
Mar 1, 2019
Completion
Mar 1, 2019
Last update
Dec 20, 2019

Study contacts

Jeff Olgin, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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