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

May 26, 2016 updated by: Kelly Haas, Stanford University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Pediatric Gastroenterology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Text Message Intervention
A series of 45 unique educational text messages sent over a period of 3 months in the evenings. Text messages include humorous reminders, links to online celiac disease resources, and bidirectional questions.
Behavioral: Educational Text Message Reminders
45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists
No Intervention: Control (No Text Messages)
Routine care by primary gastroenterologist with no text messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Transglutaminase IgA (TTG IgA)
Time Frame: 3 months
Percent change in TTG IgA for each participant pre and post study period
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deamidated Gliadin Peptide IgA (DGP IgA)
Time Frame: 3 months
Percent change in DGP IgA for each participant pre and post study period
3 months
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 months
Patient Activation Measure (PAM) score
Time Frame: 3 months
Change in Patient Activation Measure (PAM) questionnaire score pre and post study period
3 months
Patient-reported dietary adherence (CDAT) score
Time Frame: 3 months
Change in patient-reported dietary adherence (CDAT) questionnaire score pre and post study period
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Kelly B Haas, MD, Stanford Pediatric Gastroenterology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

June 1, 2015

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 26, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29967

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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