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Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis

Primary Purpose

Weight Gain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid intake app
Survey
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring hemodialysis, 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 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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vanguard

Arm Description

Participants in this arm will use the fluid intake app and take a survey to test the fluid intake monitoring app for both safety and design issues.

Outcomes

Primary Outcome Measures

Amount of interdialytic weight gain
The amount of weight gain as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.
Amount of fluid consumed
The fluid consumed as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.

Secondary Outcome Measures

Number of patients who experienced a 50% increase in fluid intake during app use
This will be a safety evaluation to ensure that no participants had more than a 50% increase in fluid intake while using the app. It will be described using descriptive statistics.
Number of days that the app was used
This will be the determination of the number of days that the app was used.
Number of days that the app was used by day of the week
Differences in app use by specific days of the week. This is a sub analysis using days of the week.
Number of days that the app was used by dialysis or non-dialysis days
Differences in app use by specific days of the week, including dialysis and non-dialysis days. This is a sub analysis using dialysis versus non-dialysis days.
Ratio of weight of liquid intake
Agreement between fluid intake and weight gain will be described using descriptive statistics by the ratio of weight of liquid intake between two visits over the interdialytic weight gain

Full Information

First Posted
November 28, 2018
Last Updated
February 24, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Danone Research
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1. Study Identification

Unique Protocol Identification Number
NCT03759847
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
hemodialysis, 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
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vanguard
Arm Type
Experimental
Arm Description
Participants in this arm will use the fluid intake app and take a survey to test the fluid intake monitoring app for both safety and design issues.
Intervention Type
Other
Intervention Name(s)
Fluid intake app
Intervention Description
Use of fluid app to monitor intake of fluids
Intervention Type
Other
Intervention Name(s)
Survey
Intervention Description
A survey will be used to assess the usability of the app (ease of use in general, ease of capturing fluid intake data, including the choice of pre-selected 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) as well as to collect recommendations for changes to the app itself.
Primary Outcome Measure Information:
Title
Amount of interdialytic weight gain
Description
The amount of weight gain as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.
Time Frame
1 month
Title
Amount of fluid consumed
Description
The fluid consumed as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of patients who experienced a 50% increase in fluid intake during app use
Description
This will be a safety evaluation to ensure that no participants had more than a 50% increase in fluid intake while using the app. It will be described using descriptive statistics.
Time Frame
1 month
Title
Number of days that the app was used
Description
This will be the determination of the number of days that the app was used.
Time Frame
1 month
Title
Number of days that the app was used by day of the week
Description
Differences in app use by specific days of the week. This is a sub analysis using days of the week.
Time Frame
1 month
Title
Number of days that the app was used by dialysis or non-dialysis days
Description
Differences in app use by specific days of the week, including dialysis and non-dialysis days. This is a sub analysis using dialysis versus non-dialysis days.
Time Frame
1 month
Title
Ratio of weight of liquid intake
Description
Agreement between fluid intake and weight gain will be described using descriptive statistics by the ratio of weight of liquid intake between two visits over the interdialytic weight gain
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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 University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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
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Citation
United States Renal Data System. 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

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