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Clinical Trials/NCT02927639
NCT02927639CompletedNot Applicable

MyDiaText: Texting the Way to Better Diabetes Control

Children's Hospital of Philadelphia1 site in 1 country166 target enrollmentStarted: July 31, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
166
Locations
1
Primary Endpoint
Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention

Experimental

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.

Intervention: MyDiaText (Other)

Control

No Intervention

This group will receive the usual standard of care for 6 months.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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