<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/NCT04440501</url>
  </required_header>
  <id_info>
    <org_study_id>56017</org_study_id>
    <nct_id>NCT04440501</nct_id>
  </id_info>
  <brief_title>Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease</brief_title>
  <acronym>VIRTUE</acronym>
  <official_title>Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease, A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      1. Specific Aim (1) is to assess both the immediate and longer term impact of VIRTUE on the&#xD;
           patient's GFD knowledge compared to standard of care (SOC) dietary education.&#xD;
&#xD;
        2. Specific Aim (2) is to determine the impact of VIRTUE on patient QoL, symptomatology,&#xD;
           and Celiac biomarkers (tissue transglutaminase antibodies, deamidated gliadin peptide&#xD;
           IgA, deamidated gliadin peptide IgG, and total serum IgA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The global burden of Celiac Disease (CD) is estimated to be 1% in Western countries and&#xD;
      0.7-1.4% of the global population.The only treatment for CD is a strict, lifelong Gluten Free&#xD;
      Diet (GFD). However, dietary adherence is the main barrier against disease control. Whereas&#xD;
      experiential learning, learning through experience, has been associated with greater impact&#xD;
      in achieving desired nutritional outcomes in pediatric populations. Replicating the&#xD;
      environments in which patients would make food choices in clinic is not feasible.&#xD;
&#xD;
      Previous research, in addition to preliminary results indicate that Virtual reality (VR) may&#xD;
      act as an effective precursor to the real world by providing a safe and immersive learning&#xD;
      environment. As such, the investigators seek to investigate how VR use to Teach, Improve&#xD;
      Outcomes, and Engage (VIRTUE) will affect patient GFD knowledge, QoL, symptoms, and CD&#xD;
      biomarkers. The central hypothesis will tested through the following specific aims:&#xD;
&#xD;
        1. Specific Aim (1) is to assess the immediate and long-term impact of VIRTUE on children's&#xD;
           GFD knowledge compared to SOC education. The investigators hypothesize that VIRTUE with&#xD;
           SOC education, will improve children's GFD knowledge by 10-20%, opposed to SOC alone&#xD;
&#xD;
        2. Specific Aim (2) is to determine the impact of VIRTUE on patient QoL. The investigators&#xD;
           hypothesize that VIRTUE with SOC education, will improve children's QoL scores, opposed&#xD;
           to SOC alone.&#xD;
&#xD;
        3. Specific Aim (3) is to determine the impact of VIRTUE on decline of CD biomarkers&#xD;
           (tissue transglutaminase antibodies and deamidated gliadin peptide IgG). The&#xD;
           investigators hypothesize that VIRTUE with SOC education, will reduce levels of CD&#xD;
           biomarkers faster, compared to SOC alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 28, 2022</start_date>
  <completion_date type="Anticipated">January 28, 2026</completion_date>
  <primary_completion_date type="Anticipated">March 28, 2025</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge of the Gluten Free Diet</measure>
    <time_frame>9 months</time_frame>
    <description>GFD-KS at the initial and clinic follow up visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CD Quality of Life</measure>
    <time_frame>9 months</time_frame>
    <description>QoL survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers to asses status of GFD</measure>
    <time_frame>6-9 months</time_frame>
    <description>Biomarkers maximum value (Ttg IgA and Dgp IgA)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Celiac Disease in Children</condition>
  <arm_group>
    <arm_group_label>Standard education (Control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard education regarding the gluten free diet by the nutritionist will be provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual Reality Program to teach gluten free diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality Goggles and education regarding the gluten free diet will be provided.&#xD;
This group will receive VIRTUE, and watch a VR educational video, and play Chaos Café, which will be administered by a research team member. This group will be prescribed to take home the VIRTUE headset and play modules for 15 minutes per week until the 6-8 month follow up.&#xD;
The VIRTUE technology will track frequency of game playing to control for adherence to the prescription.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Goggles to provide education a regarding the gluten free diet.</intervention_name>
    <description>To watch and participate in a virtual reality educational experience regarding the gluten free diet.</description>
    <arm_group_label>Virtual Reality Program to teach gluten free diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed diagnosis of CD per American or European Guidelines&#xD;
&#xD;
          -  Ages 8-18 years of all genders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Significant Developmental Delays&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nasha Khavari, MD,MPH</last_name>
    <phone>6504986295</phone>
    <email>nkhavari@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Venus Kalami, MNSP, RD</last_name>
    <email>VKalami@stanfordchildrens.org</email>
  </overall_contact_backup>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Nasim Khavari</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</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/NCT04440501
org study id: 56017
nct id: NCT04440501
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
1. Specific Aim (1) is to assess both the immediate and longer term impact of VIRTUE on the
           patient's GFD knowledge compared to standard of care (SOC) dietary education.

        2. Specific Aim (2) is to determine the impact of VIRTUE on patient QoL, symptomatology,
           and Celiac biomarkers (tissue transglutaminase antibodies, deamidated gliadin peptide
           IgA, deamidated gliadin peptide IgG, and total serum IgA).
The global burden of Celiac Disease (CD) is estimated to be 1% in Western countries and
      0.7-1.4% of the global population.The only treatment for CD is a strict, lifelong Gluten Free
      Diet (GFD). However, dietary adherence is the main barrier against disease control. Whereas
      experiential learning, learning through experience, has been associated with greater impact
      in achieving desired nutritional outcomes in pediatric populations. Replicating the
      environments in which patients would make food choices in clinic is not feasible.

      Previous research, in addition to preliminary results indicate that Virtual reality (VR) may
      act as an effective precursor to the real world by providing a safe and immersive learning
      environment. As such, the investigators seek to investigate how VR use to Teach, Improve
      Outcomes, and Engage (VIRTUE) will affect patient GFD knowledge, QoL, symptoms, and CD
      biomarkers. The central hypothesis will tested through the following specific aims:

        1. Specific Aim (1) is to assess the immediate and long-term impact of VIRTUE on children's
           GFD knowledge compared to SOC education. The investigators hypothesize that VIRTUE with
           SOC education, will improve children's GFD knowledge by 10-20%, opposed to SOC alone

        2. Specific Aim (2) is to determine the impact of VIRTUE on patient QoL. The investigators
           hypothesize that VIRTUE with SOC education, will improve children's QoL scores, opposed
           to SOC alone.

        3. Specific Aim (3) is to determine the impact of VIRTUE on decline of CD biomarkers
           (tissue transglutaminase antibodies and deamidated gliadin peptide IgG). The
           investigators hypothesize that VIRTUE with SOC education, will reduce levels of CD
           biomarkers faster, compared to SOC alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Knowledge of the Gluten Free Diet
time frame: 9 months
description: GFD-KS at the initial and clinic follow up visit
measure: CD Quality of Life
time frame: 9 months
description: QoL survey
measure: Biomarkers to asses status of GFD
time frame: 6-9 months
description: Biomarkers maximum value (Ttg IgA and Dgp IgA)
arm group label: Standard education (Control)
arm group type: No Intervention
description: Standard education regarding the gluten free diet by the nutritionist will be provided.
arm group label: Virtual Reality Program to teach gluten free diet
arm group type: Experimental
description: Virtual Reality Goggles and education regarding the gluten free diet will be provided.
This group will receive VIRTUE, and watch a VR educational video, and play Chaos Café, which will be administered by a research team member. This group will be prescribed to take home the VIRTUE headset and play modules for 15 minutes per week until the 6-8 month follow up.
The VIRTUE technology will track frequency of game playing to control for adherence to the prescription.
intervention type: Device
intervention name: Virtual Reality Goggles to provide education a regarding the gluten free diet.
description: To watch and participate in a virtual reality educational experience regarding the gluten free diet.
arm group label: Virtual Reality Program to teach gluten free diet
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nasha Khavari, MD,MPH
phone: 6504986295
email: nkhavari@stanford.edu
last name: Venus Kalami, MNSP, RD
email: VKalami@stanfordchildrens.org
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Nasim Khavari
investigator title: Clinical Associate Professor
mesh term: Celiac Disease
sharing ipd: No