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Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease (VIRTUE)

Primary Purpose

Celiac Disease in Children

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Goggles to provide education a regarding the gluten free diet.
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease in Children

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with confirmed diagnosis of CD per American or European Guidelines
  • Ages 8-18 years of all genders

Exclusion Criteria:

-Significant Developmental Delays

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard education (Control)

    Virtual Reality Program to teach gluten free diet

    Arm Description

    Standard education regarding the gluten free diet by the nutritionist will be provided.

    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.

    Outcomes

    Primary Outcome Measures

    Knowledge of the Gluten Free Diet
    GFD-KS at the initial and clinic follow up visit

    Secondary Outcome Measures

    CD Quality of Life
    QoL survey
    Biomarkers to asses status of GFD
    Biomarkers maximum value (Ttg IgA and Dgp IgA)

    Full Information

    First Posted
    June 17, 2020
    Last Updated
    April 19, 2022
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04440501
    Brief Title
    Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease
    Acronym
    VIRTUE
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 28, 2022 (Anticipated)
    Primary Completion Date
    March 28, 2025 (Anticipated)
    Study Completion Date
    January 28, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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. 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).
    Detailed Description
    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: 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 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Celiac Disease in Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard education (Control)
    Arm Type
    No Intervention
    Arm Description
    Standard education regarding the gluten free diet by the nutritionist will be provided.
    Arm Title
    Virtual Reality Program to teach gluten free diet
    Arm Type
    Experimental
    Arm 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(s)
    Virtual Reality Goggles to provide education a regarding the gluten free diet.
    Intervention Description
    To watch and participate in a virtual reality educational experience regarding the gluten free diet.
    Primary Outcome Measure Information:
    Title
    Knowledge of the Gluten Free Diet
    Description
    GFD-KS at the initial and clinic follow up visit
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    CD Quality of Life
    Description
    QoL survey
    Time Frame
    9 months
    Title
    Biomarkers to asses status of GFD
    Description
    Biomarkers maximum value (Ttg IgA and Dgp IgA)
    Time Frame
    6-9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with confirmed diagnosis of CD per American or European Guidelines Ages 8-18 years of all genders Exclusion Criteria: -Significant Developmental Delays
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nasha Khavari, MD,MPH
    Phone
    6504986295
    Email
    nkhavari@stanford.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Venus Kalami, MNSP, RD
    Email
    VKalami@stanfordchildrens.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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