Clinical trial NCT03759847: Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis
Official title: Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Keywords: hemodialysis
fluid intake
Interdialytic weight gain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2018-11-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparison of interdialytic weight gain with fluid intake as recorded by fluid app
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Amount of interdialytic weight gain
timeFrame: 1 month
measure: Amount of fluid consumed
timeFrame: 1 month
Secondary outcomes:
measure: Number of patients who experienced a 50% increase in fluid intake during app use
timeFrame: 1 month
measure: Number of days that the app was used
timeFrame: 1 month
measure: Number of days that the app was used by day of the week
timeFrame: 1 month
measure: Number of days that the app was used by dialysis or non-dialysis days
timeFrame: 1 month
measure: Ratio of weight of liquid intake
timeFrame: 1 month
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Rocco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.
citation: United States Renal Data System. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD
citation: Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583.
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citation: Chan CT, Greene T, Chertow GM, Kliger AS, Stokes JB, Beck GJ, Daugirdas JT, Kotanko P, Larive B, Levin NW, Mehta RL, Rocco M, Sanz J, Schiller BM, Yang PC, Rajagopalan S; Frequent Hemodialysis Network (FHN) Trial Group. Determinants of left ventricular mass in patients on hemodialysis: Frequent Hemodialysis Network (FHN) Trials. Circ Cardiovasc Imaging. 2012 Mar;5(2):251-61. doi: 10.1161/CIRCIMAGING.111.969923. Epub 2012 Feb 23.
citation: Chan CT, Greene T, Chertow GM, Kliger AS, Stokes JB, Beck GJ, Daugirdas JT, Kotanko P, Larive B, Levin NW, Mehta RL, Rocco M, Sanz J, Yang PC, Rajagopalan S; Frequent Hemodialysis Network Trial Group. Effects of frequent hemodialysis on ventricular volumes and left ventricular remodeling. Clin J Am Soc Nephrol. 2013 Dec;8(12):2106-16. doi: 10.2215/CJN.03280313. Epub 2013 Aug 22.
citation: Assimon MM, Wenger JB, Wang L, Flythe JE. Ultrafiltration Rate and Mortality in Maintenance Hemodialysis Patients. Am J Kidney Dis. 2016 Dec;68(6):911-922. doi: 10.1053/j.ajkd.2016.06.020. Epub 2016 Aug 26.