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

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ClinicalTrials.gov Identifier: NCT03479424
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
MYIA Labs, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment
Heart Failure With Reduced Ejection Fraction 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home Outpatient Monitoring and Engagement to Predict HF Exacerbation (HOME PREDICT-HF)
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Training Set
n = 333
Other: Observational
The MYIA in-home suite of devices.
Other Name: The MYIA in-home suite of devices.

Validation Set
n = 167
Other: Observational
The MYIA in-home suite of devices.
Other Name: The MYIA in-home suite of devices.




Primary Outcome Measures :
  1. Heart Failure Hospitalization/ ED Visit [ Time Frame: 90 day ]
    Ninety-day heart failure hospitalization/emergency department visit for heart failure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479424


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94105
Sponsors and Collaborators
University of California, San Francisco
MYIA Labs, Inc.
Investigators
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Principal Investigator: Jeff Olgin, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03479424     History of Changes
Other Study ID Numbers: 18-24445
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
hospitalization
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases