NCT04440501

Brief Summary

  1. 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. 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 28, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

2.5 years

First QC Date

June 17, 2020

Last Update Submit

April 19, 2022

Conditions

Celiac Disease in Children

Outcome Measures

Primary Outcomes (1)

  • Knowledge of the Gluten Free Diet

    GFD-KS at the initial and clinic follow up visit

    9 months

Secondary Outcomes (2)

  • CD Quality of Life

    9 months

  • Biomarkers to asses status of GFD

    6-9 months

Study Arms (2)

Standard education (Control)

NO INTERVENTION

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

Virtual Reality Program to teach gluten free diet

EXPERIMENTAL

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.

Interventions

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

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

Virtual Reality Program to teach gluten free diet

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Significant Developmental Delays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Nasha Khavari, MD,MPH

CONTACT

6504986295nkhavari@stanford.edu

Venus Kalami, MNSP, RD

CONTACT

VKalami@stanfordchildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 19, 2020

Study Start

September 28, 2022

Primary Completion

March 28, 2025

Study Completion

January 28, 2026

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share