NCT03759847

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

Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For the Vanguard phase of the trial, a survey will be used to assess the usability of the app as well as to collect recommendations for changes to the app itself (appendix one). For this Vanguard phase study, the survey for participants will be designed to assess the usability of the app (ease of use in general, ease of capturing fluid intake data, including the choice of preselected 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). The survey for the study coordinator will be designed to assess the ease of reviewing data from participants and the perceived difficulty of patient use of the app.

Conditions

• Weight Gain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-23
• Primary completion: 2021-09-27
• Completion: 2023-09-21
• First posted: 2018-11-30
• Last updated: 2024-01-09

Locations

1 site across 1 country: United States