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Clinical Trials/NCT04440501
NCT04440501
Not yet recruiting
Not Applicable

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

Stanford University0 sites100 target enrollmentSeptember 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Celiac Disease in Children
Sponsor
Stanford University
Enrollment
100
Primary Endpoint
Knowledge of the Gluten Free Diet
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

  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).

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: 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.

Registry
clinicaltrials.gov
Start Date
September 28, 2022
End Date
January 28, 2026
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nasim Khavari

Clinical Associate Professor

Stanford University

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

Outcomes

Primary Outcomes

Knowledge of the Gluten Free Diet

Time Frame: 9 months

GFD-KS at the initial and clinic follow up visit

Secondary Outcomes

  • CD Quality of Life(9 months)
  • Biomarkers to asses status of GFD(6-9 months)

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