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

NCT ID: NCT04440501

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2026-01-28

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.

Conditions

Celiac Disease in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard education (Control)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Virtual Reality Goggles to provide education a regarding the gluten free diet.

Intervention Type: DEVICE

To watch and participate in a virtual reality educational experience regarding the gluten free diet.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Nasim Khavari

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nasha Khavari, MD,MPH

Role: CONTACT

nkhavari@stanford.edu

6504986295

Venus Kalami, MNSP, RD

Role: CONTACT

VKalami@stanfordchildrens.org

Other Identifiers

56017

Identifier Type: -

Identifier Source: org_study_id