Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Tissue Transglutaminase IgA (TTG IgA)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Tissue Transglutaminase IgA (TTG IgA)
Time Frame: 3 months
Percent change in TTG IgA for each participant pre and post study period
Secondary Outcomes
- Patient-reported celiac disease symptom measure (CDI) score(3 months)
- Patient-reported dietary adherence (CDAT) score(3 months)
- Deamidated Gliadin Peptide IgA (DGP IgA)(3 months)
- NIH-PROMIS quality of life score(3 months)
- Patient Activation Measure (PAM) score(3 months)
Investigators
Kelly Haas
Principle Investigator, Pediatric Gastroenterology Fellow
Stanford University