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

• ClinicalTrials.gov Identifier: NCT04194164
• Recruitment Status: Completed
• First Posted: December 11, 2019
• Last Update Posted: February 10, 2022
• Sponsor: Wake Forest University Health Sciences
• Collaborator: Danone Research
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Tracking Information

• First Submitted Date: December 9, 2019
• First Posted Date: December 11, 2019
• Last Update Posted Date: February 10, 2022
• Actual Study Start Date: December 2, 2019
• Actual Primary Completion Date: October 11, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 9, 2019)

• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 9, 2019)

• 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) ]
• 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) ]
• 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) ]
• Number of days of app usage [ Time Frame: 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) ]
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis , Full Scale Trial
• Official Title: Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy, Full Scale Trial
• 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.

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
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Prevention

• Condition: Weight Gain

Intervention

Other: Fluid intake app

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

Study Arms

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..

Intervention: Other: Fluid intake app

Publications *

• 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. Erratum In: Am J Kidney Dis. 2016 Mar;67(3):534.
• 2. United States Renal Data System 2018. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD
• 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.
• 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. Erratum In: N Engl J Med. 2011 Jan 6;364(1):93.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 27, 2021): 33
• Original Estimated Enrollment (submitted: December 9, 2019): 60
• Actual Study Completion Date: November 1, 2021
• Actual Primary Completion Date: October 11, 2021 (Final data collection date for primary outcome measure)

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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04194164
• Other Study ID Numbers: IRB00048561a
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Wake Forest University Health Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Wake Forest University Health Sciences
• Original Study Sponsor: Same as current
• Collaborators: Danone Research

Investigators

• Principal Investigator: Michael Rocco, MD; Wake Forest University Health Sciences

• PRS Account: Wake Forest University Health Sciences
• Verification Date: September 2021