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



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:2/8/2019
Start Date:January 23, 2019
End Date:June 2019
Contact:Vicki Mauck
Email:vmauck@wakehealth.edu
Phone:336-716-2284

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

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. 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.

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.

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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Michael Rocco, MD
Phone: 336-716-2284
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