Celiac DiseaseNCT02458898
Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease
A study testing Educational Text Message Reminders in people with Celiac Disease, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Educational Text Message Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Participant inability to answer survey questions and text prompts in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Pediatric Gastroenterology Department
Palo Alto, California, 94304
About this study
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.
- Conditions
- Celiac Disease
- Being tested
- Educational Text Message Reminders
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Text Message RemindersBehavioural
45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Educational Text Message Reminders |
| Control (No Text Messages) | No intervention | Routine care by primary gastroenterologist with no text messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Transglutaminase IgA (TTG IgA)
Percent change in TTG IgA for each participant pre and post study period
Measured: 3 months
Secondary outcomes (5)
Deamidated Gliadin Peptide IgA (DGP IgA)
Percent change in DGP IgA for each participant pre and post study period
Measured: 3 months
NIH-PROMIS quality of life score
Change in NIH-PROMIS quality of life questionnaire score pre and post study period
Measured: 3 months
Patient Activation Measure (PAM) score
Change in Patient Activation Measure (PAM) questionnaire score pre and post study period
Measured: 3 months
Patient-reported dietary adherence (CDAT) score
Change in patient-reported dietary adherence (CDAT) questionnaire score pre and post study period
Measured: 3 months
Patient-reported celiac disease symptom measure (CDI) score
Change in patient-reported celiac disease symptom measure (CDI) questionnaire score pre and post study period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Haas, Stanford University
- Investigators
- Kelly B Haas, MD, Principal investigator, Stanford Pediatric Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458898
- Sponsor's protocol ID
- 29967
- Status last verified
- May 2016
- First submitted
- 21 May 2015
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28343658
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease
- ClinicalTrials.gov ID
- NCT02458898
- Acronym / sponsor ID
- 29967
- Conditions
- Celiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Message Intervention | Experimental | Behavioral: Educational Text Message RemindersA 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. |
| Control (No Text Messages) | No intervention | –Routine care by primary gastroenterologist with no text messages. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Participant inability to answer survey questions and text prompts in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Text Message Reminders45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists | Behavioural | Text Message Intervention |
Primary outcome
Tissue Transglutaminase IgA (TTG IgA)
Time frame: 3 months
Percent change in TTG IgA for each participant pre and post study period
5 secondary outcomes
Deamidated Gliadin Peptide IgA (DGP IgA)
Time frame: 3 months
NIH-PROMIS quality of life score
Time frame: 3 months
Patient Activation Measure (PAM) score
Time frame: 3 months
Patient-reported dietary adherence (CDAT) score
Time frame: 3 months
Patient-reported celiac disease symptom measure (CDI) score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Derived from this study: PubMed 28343658Haas 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.
- Study Recruitment Referral WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly B Haas, MD principal investigator
Stanford Pediatric Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Text Message Reminders in people with Celiac Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Transglutaminase IgA (TTG IgA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.