Home Outpatient Monitoring and Engagement to Predict HF Exacerbation

Heart Failure With Reduced Ejection Fraction Clinical Trial

— Home Predict  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03479424
• Other study ID #: 18-24445
• Status: Terminated
• Start date: October 8, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• Observational
The MYIA in-home suite of devices.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	MYIA Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Failure Hospitalization/ ED Visit	Ninety-day heart failure hospitalization/emergency department visit for heart failure.	90 day