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

Primary Purpose

Weight Gain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fluid intake app

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring Hemodialysis, End stage renal disease on dialysis, Fluid intake, Interdialytic weight gain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wake Forest School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluid intake app

Arm Description

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..

Outcomes

Primary Outcome Measures

Mean intradialytic weight gain

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

Mean intradialytic weight gain

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

Secondary Outcome Measures

Mean intradialytic weight gain

25th percentile of intradialytic weight gain

75th percentile of intradialytic weight gain

Number of days of app usage

Percentage of days of app usage

Number of patients who experienced at least 50% increase in fluid intake during app use

Safety evaluation.

Full Information

NCT ID

NCT04194164

First Posted

December 9, 2019

Last Updated

January 26, 2022

Sponsor

Wake Forest University Health Sciences

Collaborators

Danone Research

1. Study Identification

Unique Protocol Identification Number

NCT04194164

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

December 2, 2019 (Actual)

Primary Completion Date

October 11, 2021 (Actual)

Study Completion Date

November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

Danone Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Gain

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluid intake app

Arm Type

Experimental

Arm Description

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 Type

Other

Intervention Name(s)

Fluid intake app

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean intradialytic weight gain

Description

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

Time Frame

between baseline (pre-app) and the Active phase (months 1 and 2)

Title

Mean intradialytic weight gain

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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)

Title

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)

Title

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)

Title

Number of days of app usage

Time Frame

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

Title

Percentage of days of app usage

Time Frame

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

Title

Number of patients who experienced at least 50% increase in fluid intake during app use

Description

Safety evaluation.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Rocco, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest School of Medicine

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26498416

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. Erratum In: Am J Kidney Dis. 2016 Mar;67(3):534.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

12490682

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.

Results Reference

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PubMed Identifier

21091062

Citation

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.

Results Reference

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PubMed Identifier

22360996

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.

Results Reference

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PubMed Identifier

23970131

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.

Results Reference

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PubMed Identifier

27575009

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.

Results Reference

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

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