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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02458898
Other study ID # 29967
Secondary ID
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


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
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