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

NCT03702062 | Withdrawn

• 1 other identifier: HF1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Heart failure hospitalization

  hospital inpatient admission or emergency room visit

  12 months

Secondary Outcomes (1)

• Heart failure mortality

  12 months

Study Arms (1)

Observational Arm

EXPERIMENTAL

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

Interventions

6 Minute Walk Test Smart phone Application DIAGNOSTIC_TEST

The intervention requests participants to user the smart phone application at prescribed frequencies during the follow-up period.

Observational Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Geoffrey Tison, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: November 21, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

US (1)