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

November 5, 2020 updated by: University of California, San Francisco

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Withdrawn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

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 months
hospital inpatient admission or emergency room visit
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe