Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04440501 |
| Other study ID # |
56017 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 28, 2022 |
| Est. completion date |
January 28, 2026 |
Study information
| Verified date |
April 2022 |
| Source |
Stanford University |
| Contact |
Nasha Khavari, MD,MPH |
| Phone |
6504986295 |
| Email |
nkhavari[@]stanford.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
