MyDiaText Text Messaging Intervention for Diabetes

NCT02927639 | Completed Results DMC

• 2 other identifiers: 16-013222T32DK063688-13S1
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

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.

Other: MyDiaText

Control

NO INTERVENTION

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

Interventions

MyDiaText OTHER

The intervention will consist of daily text messages sent to the subject's personal mobile device.

Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Significant cognitive disability or major organ illness
• Hemolytic anemia

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Tara Kaushal, MD
• Organization: Children's Hospital of Philadelphia

tara.kaushal@joslin.harvard.edu

6177322603

Study Officials

• Terri Lipman, PhD

  CHOP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: July 31, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 9, 2021
• Results First Posted: November 20, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)