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Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis

NCT03759847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-01-09

No results posted yet for this study

Summary

Methods are needed to help decrease interdialytic weight gains in hemodialysis patients. One potential method for accomplishing this goal is to develop an app for smartphones that allow patients to track their fluid intake throughout the course of the day. This protocol is designed to test the safety and efficacy of this app, followed by use of the app in patients with large fluid weight gains between HD sessions. In the Vanguard phase, patients without large interdialytic fluid gains (less than 4%) will use the app to to determine the association between the interdialytic weight gain and the fluid consumed as recorded by use of the app for each interdialytic period. The app will be modified, if needed, prior to initiation of the full scale trial.

Conditions

  • Weight Gain

Interventions

OTHER

Fluid intake app

Use of fluid app to monitor intake of fluids

OTHER

Survey

A survey will be used to assess the usability of the app (ease of use in general, ease of capturing fluid intake data, including the choice of pre-selected volumes for fluid containers, reasons for not using the app more frequently, the usefulness of the app notifications, ease of sending data to the study coordinator for review) as well as to collect recommendations for changes to the app itself.

Sponsors & Collaborators

  • Danone Global Research & Innovation Center

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Michael Rocco, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2021-09-27
Completion
2023-09-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03759847 on ClinicalTrials.gov