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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Celiac Disease in Children
• Intervention / Treatment: Device: Virtual Reality Goggles to provide education a regarding the gluten free diet.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nasha Khavari, MD,MPH; Phone Number: 6504986295; Email: nkhavari@stanford.edu
• Study Contact Backup: Name: Venus Kalami, MNSP, RD; Email: VKalami@stanfordchildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard education (Control); Standard education regarding the gluten free diet by the nutritionist will be provided.
Experimental: Virtual Reality Program to teach gluten free diet; 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.	Device: Virtual Reality Goggles to provide education a regarding the gluten free diet.; To watch and participate in a virtual reality educational experience regarding the gluten free diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of the Gluten Free Diet	GFD-KS at the initial and clinic follow up visit	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD Quality of Life	QoL survey	9 months
Biomarkers to asses status of GFD	Biomarkers maximum value (Ttg IgA and Dgp IgA)	6-9 months

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 28, 2022
• Primary Completion (Anticipated): March 28, 2025
• Study Completion (Anticipated): January 28, 2026

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 56017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No