Celiac Disease in ChildrenVIRTUENCT04440501
Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease
A study testing Virtual Reality Goggles to provide education a regarding the gluten free diet. in people with Celiac Disease in Children, run by Stanford University.
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… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children
- What is being tested?
- Virtual Reality Goggles to provide education a regarding the gluten free diet.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2022to 28 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with confirmed diagnosis of CD per American or European Guidelines
- Ages 8-18 years of all genders
Who cannot join
- -Significant Developmental Delays
Trial locations and contacts
No sites are listed yet.
Venus Kalami, MNSP, RD contact
About this study
Official title: 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
- 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.
- 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).
Read the 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:
- 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
- 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.
- 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
- Being tested
- Virtual Reality Goggles to provide education a regarding the gluten free diet.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality Goggles to provide education a regarding the gluten free diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of the Gluten Free Diet
GFD-KS at the initial and clinic follow up visit
Measured: 9 months
Secondary outcomes (2)
CD Quality of Life
QoL survey
Measured: 9 months
Biomarkers to asses status of GFD
Biomarkers maximum value (Ttg IgA and Dgp IgA)
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start28 Sep 2022 (estimated)
- Primary completion28 Mar 2025 (estimated)
- Study completion28 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasim Khavari, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440501
- Sponsor's protocol ID
- 56017
- Acronym
- VIRTUE
- Status last verified
- Apr 2022
- First submitted
- 17 Jun 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04440501
- Acronym / sponsor ID
- VIRTUE / 56017
- Conditions
- Celiac Disease in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 28 Sep 2022 (estimated)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 28 Jan 2026 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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:
- 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
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Virtual Reality Goggles to provide education a regarding the 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis of CD per American or European Guidelines
- Ages 8-18 years of all genders
Key exclusion criteria (1 listed)
- -Significant Developmental Delays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Virtual Reality Program to teach gluten free diet |
Primary outcome
Knowledge of the Gluten Free Diet
Time frame: 9 months
GFD-KS at the initial and clinic follow up visit
2 secondary outcomes
CD Quality of Life
Time frame: 9 months
Biomarkers to asses status of GFD
Time frame: 6-9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venus Kalami, MNSP, RD contact
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Goggles to provide education a regarding the gluten free diet. in people with Celiac Disease in Children, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasha Khavari, MD,MPH (6504986295, nkhavari@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of the Gluten Free Diet (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.