- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927639
MyDiaText Text Messaging Intervention for Diabetes
May 17, 2021 updated by: Children's Hospital of Philadelphia
MyDiaText: Texting the Way to Better Diabetes Control
To test a text messaging intervention using MyDiaText and financial incentives to determine whether such an intervention will improve self-reported self-care behaviors in children 12 to 18 years old.
The intervention will consist of daily text messages sent to the subject's personal mobile device.
Subjects will be incentivized to respond to text messages via a lottery financial incentive.
Previously developed text messages based on the American Diabetes Association (ADA) behavior goals will be used for this intervention.
Study Overview
Study Type
Interventional
Enrollment (Actual)
166
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
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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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 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of type 1 diabetes for more than 1 year
- HbA1c greater than or equal to 8% but less than 14%.
- Have been seen in diabetes clinic in the last 6 months
- Owns a personal mobile device with unlimited text messaging plan
Exclusion Criteria:
- Non-English speaking
- Significant cognitive disability or major organ illness
- Hemolytic anemia
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
This group will receive the intervention for 6 months.
The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care.
Subjects will be incentivized to respond to text messages via a financial reward lottery system.
Previously developed text messages based on the ADA behavior goals will be used for this intervention.
|
The intervention will consist of daily text messages sent to the subject's personal mobile device.
|
No Intervention: Control
This group will receive the usual standard of care for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months
Time Frame: 6 months
|
Estimate of self-management will be assessed via the Self-Care Inventory questionnaire.
This scale measures self-reported adherence to diabetes self-care behaviors.
A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes.
The outcome was mean score on the scale.
If a participant responded N/A, this question was not included in calculation of mean score.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
Time Frame: 6 months
|
Hemoglobin A1c is a measure of glycemic control scale that reflects how well they followed recommendations for self-care during the past month (1="never do it" to 5 ="always do this as recommended, without fail").
Total scores range from 1-70 and previous data shows that youth with better self-care levels (higher scores) have significantly better glycemic control.
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Terri Lipman, PhD, CHOP
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 (Actual)
July 31, 2018
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
October 6, 2016
First Posted (Estimate)
October 7, 2016
Study Record Updates
Last Update Posted (Actual)
June 9, 2021
Last Update Submitted That Met QC Criteria
May 17, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-013222
- T32DK063688-13S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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