Dynamic Heart Failure Prediction With Real-time Functional Status Data in the Ambulatory Setting

Dynamic Prediction of Heart Failure Using Real-time Functional Status and Electronic Health Record Data in the Ambulatory Setting

Heart failure is the number one cause of hospital readmission in those over 65 years of age and the current standard-of-care of weight self-monitoring is inadequate to predict exacerbation. This project aims to improve the monitoring of heart failure disease progression through the use of real-time, up-to-date data obtained both from a smart phone-based tool and from the electronic health record. The goal is to develop a low-risk, clinically validated method to estimate dynamic heart failure risk to enable the provision of earlier, more effective outpatient interventions that decrease hospitalization.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: 6 Minute Walk Test Smart phone Application

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospitalized for decompensated heart failure
• Age >=18 years
• Owns a smart phone
• Willing to measure self assess 6 minute walk test weekly

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Observational Arm; Participants will be asked to measure self-assessed 6 minute walk test via the smart phone application twice a week for 2 months after discharge from a heart failure hospitalization, and weekly thereafter for 6 months.	Diagnostic test: 6 Minute Walk Test Smart phone Application; The intervention requests participants to user the smart phone application at prescribed frequencies during the follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure hospitalization	hospital inpatient admission or emergency room visit	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure mortality	Death from heart failure	12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Geoffrey Tison, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Anticipated): November 21, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HF1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No