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Completed

NCT Number: NCT03759847

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

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.

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Key information

Conditions

Weight Gain Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study.
  • Adult chronic hemodialysis patients who are at least 18 years of age
  • Average interdialytic fluid gains of less than 4% of body weight for both weekdays and weekends for a 30 day period
  • Access to a smartphone for use of the app and comfort with using apps on a regular basis
  • Access to a smartphone running under either iOS or Android operating systems
  • Sufficient knowledge and understanding of the English language to use the application available only in English (US) language
  • Mental capacity to use and understand the fluid management app
  • Willingness to share intake data collected with the research team

Exclusion criteria

  • Scheduled for a living related renal transplant in the next four months
  • Class III or IV heart failure
  • Need for chronic oxygen therapy due to pulmonary disease
  • Hospitalization within 30 days of entry into the study
  • Current participation in a randomized clinical trial or in the exclusion period of another clinical trial

Treatment and study plan

Fluid intake app

Other

Use of fluid app to monitor intake of fluids

Survey

Other

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.

Primary outcomes

  1. Amount of interdialytic weight gain

    Time frame: 1 month

    The amount of weight gain as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.

  2. Amount of fluid consumed

    Time frame: 1 month

    The fluid consumed as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.

Secondary outcomes

  1. Number of patients who experienced a 50% increase in fluid intake during app use

    Time frame: 1 month

    This will be a safety evaluation to ensure that no participants had more than a 50% increase in fluid intake while using the app. It will be described using descriptive statistics.

  2. Number of days that the app was used

    Time frame: 1 month

    This will be the determination of the number of days that the app was used.

  3. Number of days that the app was used by day of the week

    Time frame: 1 month

    Differences in app use by specific days of the week. This is a sub analysis using days of the week.

  4. Number of days that the app was used by dialysis or non-dialysis days

    Time frame: 1 month

    Differences in app use by specific days of the week, including dialysis and non-dialysis days. This is a sub analysis using dialysis versus non-dialysis days.

  5. Ratio of weight of liquid intake

    Time frame: 1 month

    Agreement between fluid intake and weight gain will be described using descriptive statistics by the ratio of weight of liquid intake between two visits over the interdialytic weight gain

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Danone Global Research & Innovation Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Nov 30, 2018
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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