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

NCT03759847 | Completed

• 1 other identifier: IRB00048561
• Study Type: interventional
• Target: 28
• 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. 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.

Conditions

Weight Gain

Keywords

hemodialysis; fluid intake; Interdialytic weight gain

Outcome Measures

Primary Outcomes (2)

• 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.

  1 month

• 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.

  1 month

Secondary Outcomes (5)

• Number of patients who experienced a 50% increase in fluid intake during app use

  1 month

• Number of days that the app was used

  1 month

• Number of days that the app was used by day of the week

  1 month

• Number of days that the app was used by dialysis or non-dialysis days

  1 month

• Ratio of weight of liquid intake

  1 month

Study Arms (1)

Vanguard

EXPERIMENTAL

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.

Other: Fluid intake app; Other: Survey

Interventions

Fluid intake app OTHER

Use of fluid app to monitor intake of fluids

Vanguard

Survey OTHER

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.

Vanguard

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (8)

• 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

• United States Renal Data System. 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

• Rocco MV, Rigaud M, Ertel C, Russell G, Zemdegs J, Vecchio M. Fluid Intake Management in Maintenance Hemodialysis Using a Smartphone-Based Application: A Pilot Study. Kidney Med. 2023 Jul 26;5(9):100703. doi: 10.1016/j.xkme.2023.100703. eCollection 2023 Sep.

  PMID: 37663954 DERIVED

MeSH Terms

Conditions

Weight Gain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

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: November 28, 2018
• First Posted: November 30, 2018
• Study Start: January 23, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 21, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)