Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis , Full Scale Trial

January 26, 2022 updated by: Wake Forest University Health Sciences

Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy, Full Scale Trial

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. NCT 03759847 was designed to test the safety and efficacy of this app. In this protocol, part of the same IRB number, patients with large interdialytic fluid gains (3.5% or greater) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this full scale study, the app will be used to try and influence fluid intake behavior in those patients who are identified to have large fluid weight gains, as defined by a greater than 4% increase in interdialytic weight.

There will be two parts to the full scale trial. In the first part of the full scale study, denoted as the active phase, which will last for two months, study participants will be encouraged to use the app on a daily basis and will meet with the study coordinator on weeks 1, 2, 4, 6, and 8 to further assist the participant in decreasing fluid intake between dialysis sessions. In the second portion of the study, denoted as the passive phase, which will last for six months, the patient will use the app and meet with the study coordinator only when requested by the patient. The number of these sessions will be recorded. At the end of the six month passive phase, the participant will meet for the last time with the study coordinator. During each study visit, subjects will be asked to transfer the data from the App to the study coordinator via the data export function of the app.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 patient who is at least 18 years of age
  • Average interdialytic fluid gains of 3.5% or greater of body weight for both weekdays and weekends for a 30 day period
  • Availability of interdialytic weight gains for the 2 month period prior to enrollment into the study
  • 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 seven months
  • 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
  • Vulnerable subjects defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fluid intake app
Participants in this arm will use the fluid intake app to help them decrease interdialytic fluid intake. Participants will take a survey to assess the efficacy of the fluid app..
Other: Fluid intake app
Monitor fluid intake and interdialytic weight gain in patients using the fluid app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean intradialytic weight gain
Time Frame: between baseline (pre-app) and the Active phase (months 1 and 2)
Comparison of interdialytic weight change before and during use of the app
between baseline (pre-app) and the Active phase (months 1 and 2)
Mean intradialytic weight gain
Time Frame: between baseline (pre-app) and the Passive phase (month 3-8)
Comparison of interdialytic weight change before and during use of the app
between baseline (pre-app) and the Passive phase (month 3-8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean intradialytic weight gain
Time Frame: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
25th percentile of intradialytic weight gain
Time Frame: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
75th percentile of intradialytic weight gain
Time Frame: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
Number of days of app usage
Time Frame: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Percentage of days of app usage
Time Frame: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Number of patients who experienced at least 50% increase in fluid intake during app use
Time Frame: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Safety evaluation.
the Active phase (months 1 and 2), Passive phase (month 3 through month 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Danone Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 2, 2019

Primary Completion (ACTUAL)

October 11, 2021

Study Completion (ACTUAL)

November 1, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (ACTUAL)

December 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00048561a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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