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MyDiaText Text Messaging Intervention for Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyDiaText
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Self-Care Inventory (SCI) Score From Baseline to 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 Outcome Measures

Change in Hemoglobin A1c (HbA1c) From Baseline to 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.

Full Information

First Posted
October 6, 2016
Last Updated
May 17, 2021
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02927639
Brief Title
MyDiaText Text Messaging Intervention for Diabetes
Official Title
MyDiaText: Texting the Way to Better Diabetes Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive the usual standard of care for 6 months.
Intervention Type
Other
Intervention Name(s)
MyDiaText
Intervention Description
The intervention will consist of daily text messages sent to the subject's personal mobile device.
Primary Outcome Measure Information:
Title
Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terri Lipman, PhD
Organizational Affiliation
CHOP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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MyDiaText Text Messaging Intervention for Diabetes

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