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Clinical Trials/NCT02458898
NCT02458898
Completed
Not Applicable

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

Stanford University1 site in 1 country61 target enrollmentFebruary 2015
ConditionsCeliac Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Celiac Disease
Sponsor
Stanford University
Enrollment
61
Locations
1
Primary Endpoint
Tissue Transglutaminase IgA (TTG IgA)
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly Haas

Principle Investigator, Pediatric Gastroenterology Fellow

Stanford University

Eligibility Criteria

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)

Study Sites (1)

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