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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194164
Recruitment Status : Completed
First Posted : December 11, 2019
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Gain Other: Fluid intake app Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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
Official Title: Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy, Full Scale Trial
Actual Study Start Date : December 2, 2019
Actual Primary Completion Date : October 11, 2021
Actual Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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..
 Other: Fluid intake app
Monitor fluid intake and interdialytic weight gain in patients using the fluid app


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. Number of days of app usage [ Time Frame: the Active phase (months 1 and 2), Passive phase (month 3 through month 8) ]
  5. Percentage of days of app usage [ Time Frame: the Active phase (months 1 and 2), Passive phase (month 3 through month 8) ]
  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194164


Locations
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United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Danone Research
Investigators
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Principal Investigator: Michael Rocco, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Informed Consent Form  [PDF] November 11, 2020

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

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04194164    
Other Study ID Numbers: IRB00048561a
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Hemodialysis
End stage renal disease on dialysis
Fluid intake
Interdialytic weight gain
Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight