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

NCT ID: NCT02458898

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational Text Message Reminders

Intervention Type BEHAVIORAL

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

Control (No Text Messages)

Routine care by primary gastroenterologist with no text messages.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational Text Message Reminders

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Kelly Haas

Principle Investigator, Pediatric Gastroenterology Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kelly B Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Pediatric Gastroenterology

Locations

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Stanford University Pediatric Gastroenterology Department

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28343658 (View on PubMed)

Related Links

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https://redcap.stanford.edu/surveys/?s=HYTNWHRAT4

Study Recruitment Referral Website

Other Identifiers

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29967

Identifier Type: -

Identifier Source: org_study_id

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