Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease

Study Overview
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Brief Summary
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This is a prospective randomized controlled trial investigating the impact of educational bidirectional text message reminders on gluten free diet adherence among adolescents and young adults with celiac disease age 12-24. Participants will complete a series of online questionnaires assessing quality of life, patient activation, celiac symptoms, and self reported dietary adherence at the beginning and end of the study. Participants will also have their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and Deamidated Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws can be done locally, and are at no cost to the participant. Patients are randomized to the intervention or control group based on enrollment TTG IgA. Intervention group receives 45 unique text messages over the 3 month study. A gift card is provided for participation in the study.

Official Title
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Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease

Conditions
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Celiac Disease

Intervention / Treatment
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* Behavioral: Educational Text Message Reminders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12-24 Celiac disease diagnosed by a gastroenterologist at least 1 year prior to enrollment Participant with ability to read email and text messages in English Access to a mobile phone Unlimited text messaging plan or agreement to receive 45 text messages for the study Exclusion Criteria: Participant inability to answer survey questions and text prompts in English

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text Message Intervention<br>A series of 45 unique educational text messages sent over a period of 3 months in the evenings. Text messages include humorous reminders, links to online celiac disease resources, and bidirectional questions. | Behavioral: Educational Text Message Reminders<br>* 45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists<br>|
| No Intervention: Control (No Text Messages)<br>Routine care by primary gastroenterologist with no text messages. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Transglutaminase IgA (TTG IgA) | Percent change in TTG IgA for each participant pre and post study period | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deamidated Gliadin Peptide IgA (DGP IgA) | Percent change in DGP IgA for each participant pre and post study period | 3 months | 
| NIH-PROMIS quality of life score | Change in NIH-PROMIS quality of life questionnaire score pre and post study period | 3 months | 
| Patient Activation Measure (PAM) score | Change in Patient Activation Measure (PAM) questionnaire score pre and post study period | 3 months | 
| Patient-reported dietary adherence (CDAT) score | Change in patient-reported dietary adherence (CDAT) questionnaire score pre and post study period | 3 months | 
| Patient-reported celiac disease symptom measure (CDI) score | Change in patient-reported celiac disease symptom measure (CDI) questionnaire score pre and post study period | 3 months |