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

NCT04194164 | Completed

• 1 other identifier: IRB00048561a
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Weight Gain

Keywords

Hemodialysis; End stage renal disease on dialysis; Fluid intake; Interdialytic weight gain

Outcome Measures

Primary Outcomes (2)

• Mean intradialytic weight gain

  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

  Comparison of interdialytic weight change before and during use of the app

  between baseline (pre-app) and the Passive phase (month 3-8)

Secondary Outcomes (6)

• Mean intradialytic weight gain

  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

  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

  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

  the Active phase (months 1 and 2), Passive phase (month 3 through month 8)

• Percentage of days of app usage

  the Active phase (months 1 and 2), Passive phase (month 3 through month 8)

Study Arms (1)

Fluid intake app

EXPERIMENTAL

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

Interventions

Fluid intake app OTHER

Monitor fluid intake and interdialytic weight gain in patients using the fluid app

Fluid intake app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Scheduled for a living related renal transplant in the next seven months
• Hospitalization within 30 days of entry into the study
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (7)

• 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.

  PMID: 26498416 BACKGROUND

• 2. United States Renal Data System 2018. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD

  BACKGROUND

• 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.

  PMID: 12490682 BACKGROUND

• FHN Trial Group; Chertow GM, Levin NW, Beck GJ, Depner TA, Eggers PW, Gassman JJ, Gorodetskaya I, Greene T, James S, Larive B, Lindsay RM, Mehta RL, Miller B, Ornt DB, Rajagopalan S, Rastogi A, Rocco MV, Schiller B, Sergeyeva O, Schulman G, Ting GO, Unruh ML, Star RA, Kliger AS. In-center hemodialysis six times per week versus three times per week. N Engl J Med. 2010 Dec 9;363(24):2287-300. doi: 10.1056/NEJMoa1001593. Epub 2010 Nov 20.

  PMID: 21091062 BACKGROUND

• 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.

  PMID: 22360996 BACKGROUND

• 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.

  PMID: 23970131 BACKGROUND

• 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.

  PMID: 27575009 BACKGROUND

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Rocco, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of interdialytic weight gain with fluid intake as recorded by fluid app

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: December 2, 2019
• Primary Completion: October 11, 2021
• Study Completion: November 1, 2021
• Last Updated: February 10, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)