<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/NCT04403633</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00104197</org_study_id>
    <secondary_id>1R38HL143612-01</secondary_id>
    <nct_id>NCT04403633</nct_id>
  </id_info>
  <brief_title>A Study of Facilitators and Barriers to Improve Acute Kidney Injury in Children Through Mobile Health Intervention</brief_title>
  <official_title>Improving Patient-Centered Care in Pediatric Acute Kidney Injury (Change Peds AKI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to improve patient-centered care for acute kidney injury (AKI)&#xD;
      in order to decrease the adverse health outcomes associated with this common condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a need to provide better patient-centered care for acute kidney injury (AKI) in&#xD;
      order to improve the adverse health outcomes associated with this common condition. This&#xD;
      project involves thorough evaluation of patient and provider feedback on barriers and&#xD;
      facilitators to pediatric AKI self-management in order to develop patient-centered pediatric&#xD;
      AKI interventions. This will be done through interviews with families of patients diagnosed&#xD;
      with AKI and providers who take care of these patients followed by integration of the results&#xD;
      into modification of an existing educational tool previously used in adult patients. The&#xD;
      study will take place in three parts with the first involving interviews, the second&#xD;
      involving tool modification and usability testing, and the third involving pilot testing of&#xD;
      the tool's impact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Kidney Injury (AKI) Knowledge Assessment score</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>AKI Knowledge Assessment administered as pre-test prior to intervention and post-test one month after intervention. This assessment is scored with minimum value of 0% and maximum value of 100%. A higher score is a better outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Receiving Educational Tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive the educational tool after the pretest in addition to usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Receiving Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will receive usual care after the pretest.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mobile health educational tool</intervention_name>
    <description>Interactive educational tool delivered on iPad</description>
    <arm_group_label>Receiving Educational Tool</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 1 to 18 years&#xD;
&#xD;
          -  patients with diagnosis of AKI while hospitalized&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  legal blindness of deafness&#xD;
&#xD;
          -  cognitive impairment that limits ability to consent&#xD;
&#xD;
          -  non-English speaking&#xD;
&#xD;
          -  patient age greater than age 18 years, 11 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clarissa J Diamantidis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rasheed Gbadegesin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna Williams</last_name>
    <phone>919-684-4246</phone>
    <email>anna.e.williams@duke.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Burks</last_name>
      <phone>919-681-4374</phone>
      <email>erin.burks@duke.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AKI</keyword>
  <keyword>Pediatric AKI</keyword>
  <keyword>Acute Kidney Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04403633
org study id: Pro00104197
secondary id: 1R38HL143612-01
nct id: NCT04403633
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to improve patient-centered care for acute kidney injury (AKI)
      in order to decrease the adverse health outcomes associated with this common condition.
There is a need to provide better patient-centered care for acute kidney injury (AKI) in
      order to improve the adverse health outcomes associated with this common condition. This
      project involves thorough evaluation of patient and provider feedback on barriers and
      facilitators to pediatric AKI self-management in order to develop patient-centered pediatric
      AKI interventions. This will be done through interviews with families of patients diagnosed
      with AKI and providers who take care of these patients followed by integration of the results
      into modification of an existing educational tool previously used in adult patients. The
      study will take place in three parts with the first involving interviews, the second
      involving tool modification and usability testing, and the third involving pilot testing of
      the tool's impact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Acute Kidney Injury (AKI) Knowledge Assessment score
time frame: Baseline, 1 month
description: AKI Knowledge Assessment administered as pre-test prior to intervention and post-test one month after intervention. This assessment is scored with minimum value of 0% and maximum value of 100%. A higher score is a better outcome.
arm group label: Receiving Educational Tool
arm group type: Experimental
description: Patients in this arm will receive the educational tool after the pretest in addition to usual care.
arm group label: Receiving Usual Care
arm group type: No Intervention
description: Patients in this arm will receive usual care after the pretest.
intervention type: Other
intervention name: mobile health educational tool
description: Interactive educational tool delivered on iPad
arm group label: Receiving Educational Tool
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Clarissa J Diamantidis, MD
role: Principal Investigator
affiliation: Duke University
last name: Rasheed Gbadegesin, MD
role: Principal Investigator
affiliation: Duke University
last name: Anna Williams
phone: 919-684-4246
email: anna.e.williams@duke.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No