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

Primary Purpose

Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6 Minute Walk Test Smart phone Application
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Observational Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Heart failure hospitalization
hospital inpatient admission or emergency room visit

Secondary Outcome Measures

Heart failure mortality
Death from heart failure

Full Information

First Posted
October 8, 2018
Last Updated
November 5, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03702062
Brief Title
Dynamic Heart Failure Prediction With Real-time Functional Status Data in the Ambulatory Setting
Official Title
Dynamic Prediction of Heart Failure Using Real-time Functional Status and Electronic Health Record Data in the Ambulatory Setting
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started
Study Start Date
November 21, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observational Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
6 Minute Walk Test Smart phone Application
Intervention Description
The intervention requests participants to user the smart phone application at prescribed frequencies during the follow-up period.
Primary Outcome Measure Information:
Title
Heart failure hospitalization
Description
hospital inpatient admission or emergency room visit
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Heart failure mortality
Description
Death from heart failure
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Tison, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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