NCT02458898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

May 21, 2015

Last Update Submit

May 26, 2016

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

  • Tissue Transglutaminase IgA (TTG IgA)

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

    3 months

Secondary Outcomes (5)

  • Deamidated Gliadin Peptide IgA (DGP IgA)

    3 months

  • NIH-PROMIS quality of life score

    3 months

  • Patient Activation Measure (PAM) score

    3 months

  • Patient-reported dietary adherence (CDAT) score

    3 months

  • Patient-reported celiac disease symptom measure (CDI) score

    3 months

Study Arms (2)

Text Message Intervention

EXPERIMENTAL

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

Control (No Text Messages)

NO INTERVENTION

Routine care by primary gastroenterologist with no text messages.

Interventions

Educational Text Message RemindersBEHAVIORAL

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

Text Message Intervention

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Participant inability to answer survey questions and text prompts in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Pediatric Gastroenterology Department

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • Haas K, Martin A, Park KT. Text Message Intervention (TEACH) Improves Quality of Life and Patient Activation in Celiac Disease: A Randomized Clinical Trial. J Pediatr. 2017 Jun;185:62-67.e2. doi: 10.1016/j.jpeds.2017.02.062. Epub 2017 Mar 23.

    PMID: 28343658DERIVED

Related Links

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kelly B Haas, MD

    Stanford Pediatric Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Pediatric Gastroenterology Fellow

Study Record Dates

First Submitted

May 21, 2015

First Posted

June 1, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 27, 2016

Record last verified: 2016-05

Locations

US(1)