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

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458898
• Other study ID #: 29967
• Status: Completed
• Phase: N/A
• First received: May 21, 2015
• Last updated: May 26, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 24 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Behavioral:
• Educational Text Message Reminders
45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists

Locations

Country	Name	City	State
United States	Stanford University Pediatric Gastroenterology Department	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue Transglutaminase IgA (TTG IgA)	Percent change in TTG IgA for each participant pre and post study period	3 months	No
Secondary	Deamidated Gliadin Peptide IgA (DGP IgA)	Percent change in DGP IgA for each participant pre and post study period	3 months	No
Secondary	NIH-PROMIS quality of life score	Change in NIH-PROMIS quality of life questionnaire score pre and post study period	3 months	No
Secondary	Patient Activation Measure (PAM) score	Change in Patient Activation Measure (PAM) questionnaire score pre and post study period	3 months	No
Secondary	Patient-reported dietary adherence (CDAT) score	Change in patient-reported dietary adherence (CDAT) questionnaire score pre and post study period	3 months	No
Secondary	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	No

External Links

•   Study Recruitment Referral Website