<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759847</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00048561</org_study_id>
    <nct_id>NCT03759847</nct_id>
  </id_info>
  <brief_title>Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis</brief_title>
  <official_title>Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danone Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Methods are needed to help decrease interdialytic weight gains in hemodialysis patients. One&#xD;
      potential method for accomplishing this goal is to develop an app for smartphones that allow&#xD;
      patients to track their fluid intake throughout the course of the day. This protocol is&#xD;
      designed to test the safety and efficacy of this app, followed by use of the app in patients&#xD;
      with large fluid weight gains between HD sessions. In the Vanguard phase, patients without&#xD;
      large interdialytic fluid gains (less than 4%) will use the app to to determine the&#xD;
      association between the interdialytic weight gain and the fluid consumed as recorded by use&#xD;
      of the app for each interdialytic period. The app will be modified, if needed, prior to&#xD;
      initiation of the full scale trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the Vanguard phase of the trial, a survey will be used to assess the usability of the app&#xD;
      as well as to collect recommendations for changes to the app itself (appendix one). For this&#xD;
      Vanguard phase study, the survey for participants will be designed to assess the usability of&#xD;
      the app (ease of use in general, ease of capturing fluid intake data, including the choice of&#xD;
      preselected volumes for fluid containers, reasons for not using the app more frequently, the&#xD;
      usefulness of the app notifications, ease of sending data to the study coordinator for&#xD;
      review). The survey for the study coordinator will be designed to assess the ease of&#xD;
      reviewing data from participants and the perceived difficulty of patient use of the app.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">September 27, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Comparison of interdialytic weight gain with fluid intake as recorded by fluid app</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of interdialytic weight gain</measure>
    <time_frame>1 month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of fluid consumed</measure>
    <time_frame>1 month</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who experienced a 50% increase in fluid intake during app use</measure>
    <time_frame>1 month</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days that the app was used</measure>
    <time_frame>1 month</time_frame>
    <description>This will be the determination of the number of days that the app was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days that the app was used by day of the week</measure>
    <time_frame>1 month</time_frame>
    <description>Differences in app use by specific days of the week. This is a sub analysis using days of the week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days that the app was used by dialysis or non-dialysis days</measure>
    <time_frame>1 month</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of weight of liquid intake</measure>
    <time_frame>1 month</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Weight Gain</condition>
  <arm_group>
    <arm_group_label>Vanguard</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluid intake app</intervention_name>
    <description>Use of fluid app to monitor intake of fluids</description>
    <arm_group_label>Vanguard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <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.</description>
    <arm_group_label>Vanguard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject, upon briefing of the content of the present study, fully understanding and&#xD;
             agreeing to its objective and having given written (dated and signed) informed consent&#xD;
             form to take part in the study.&#xD;
&#xD;
          -  Adult chronic hemodialysis patients who are at least 18 years of age&#xD;
&#xD;
          -  Average interdialytic fluid gains of less than 4% of body weight for both weekdays and&#xD;
             weekends for a 30 day period&#xD;
&#xD;
          -  Access to a smartphone for use of the app and comfort with using apps on a regular&#xD;
             basis&#xD;
&#xD;
          -  Access to a smartphone running under either iOS or Android operating systems&#xD;
&#xD;
          -  Sufficient knowledge and understanding of the English language to use the application&#xD;
             available only in English (US) language&#xD;
&#xD;
          -  Mental capacity to use and understand the fluid management app&#xD;
&#xD;
          -  Willingness to share intake data collected with the research team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Scheduled for a living related renal transplant in the next four months&#xD;
&#xD;
          -  Class III or IV heart failure&#xD;
&#xD;
          -  Need for chronic oxygen therapy due to pulmonary disease&#xD;
&#xD;
          -  Hospitalization within 30 days of entry into the study&#xD;
&#xD;
          -  Current participation in a randomized clinical trial or in the exclusion period of&#xD;
             another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Rocco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>26498416</PMID>
  </reference>
  <reference>
    <citation>United States Renal Data System. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12490682</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21091062</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22360996</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23970131</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27575009</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemodialysis</keyword>
  <keyword>fluid intake</keyword>
  <keyword>Interdialytic weight gain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Gain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759847
org study id: IRB00048561
nct id: NCT03759847
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Comparison of interdialytic weight gain with fluid intake as recorded by fluid app
primary purpose: Prevention
masking: None (Open Label)
measure: Amount of interdialytic weight gain
time frame: 1 month
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.
measure: Amount of fluid consumed
time frame: 1 month
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.
measure: Number of patients who experienced a 50% increase in fluid intake during app use
time frame: 1 month
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.
measure: Number of days that the app was used
time frame: 1 month
description: This will be the determination of the number of days that the app was used.
measure: Number of days that the app was used by day of the week
time frame: 1 month
description: Differences in app use by specific days of the week. This is a sub analysis using days of the week.
measure: Number of days that the app was used by dialysis or non-dialysis days
time frame: 1 month
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.
measure: Ratio of weight of liquid intake
time frame: 1 month
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
arm group label: Vanguard
arm group type: Experimental
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: Fluid intake app
description: Use of fluid app to monitor intake of fluids
arm group label: Vanguard
intervention type: Other
intervention name: Survey
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.
arm group label: Vanguard
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Rocco, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
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.
PMID: 26498416
citation: United States Renal Data System. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD
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.
PMID: 12490682
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.
PMID: 21091062
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.
PMID: 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, 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
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.
PMID: 27575009
responsible party type: Sponsor
mesh term: Weight Gain
sharing ipd: No