Status:
COMPLETED
Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Danone Global Research & Innovation Center
Conditions:
Weight Gain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 tr...
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 phas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03759847
Start Date
January 23 2019
End Date
September 21 2023
Last Update
January 9 2024
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157