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OpenTrials
Completed

NCT Number: NCT02458898

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

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Pediatric Gastroenterology Department

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Text Message Reminders

Behavioral

45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists

Primary outcomes

  1. Tissue Transglutaminase IgA (TTG IgA)

    Time frame: 3 months

    Percent change in TTG IgA for each participant pre and post study period

Secondary outcomes

  1. Deamidated Gliadin Peptide IgA (DGP IgA)

    Time frame: 3 months

    Percent change in DGP IgA for each participant pre and post study period

  2. NIH-PROMIS quality of life score

    Time frame: 3 months

    Change in NIH-PROMIS quality of life questionnaire score pre and post study period

  3. Patient Activation Measure (PAM) score

    Time frame: 3 months

    Change in Patient Activation Measure (PAM) questionnaire score pre and post study period

  4. Patient-reported dietary adherence (CDAT) score

    Time frame: 3 months

    Change in patient-reported dietary adherence (CDAT) questionnaire score pre and post study period

  5. Patient-reported celiac disease symptom measure (CDI) score

    Time frame: 3 months

    Change in patient-reported celiac disease symptom measure (CDI) questionnaire score pre and post study period

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2015
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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