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Clinical Trials/NCT03241212
NCT03241212CompletedNot Applicable

Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)

University of Colorado, Denver1 site in 1 country148 target enrollmentStarted: September 12, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
148
Locations
1
Primary Endpoint
Change in knowledge about type 1 diabetes

Study Overview

Brief Summary

This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3 months and 6 months. The intervention group will receive a minimum of 78 text messages related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited to respond to some text messages which will be in the form of a multiple-choice question and if they do, they will receive an additional text message in response to their answer.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
15 Years to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Diagnosis of type 1 diabetes mellitus
  • •Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
  • •Age 15-20 at study enrollment
  • •English literate and English speaking
  • •Ability to complete the required surveys
  • •Have a personal cell phone with service compatible with EZTexting Platform
  • •Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).

Exclusion Criteria

  • •Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
  • •Diabetes Diagnosis other than Type 1 Diabetes
  • •Inability for the adolescent to respond to text messages (e.g. due to developmental delay)

Arms & Interventions

Control

No Intervention

At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review.

Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment.

Texting

Experimental

Participants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software.

From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.

Intervention: Texting (Behavioral)

Outcomes

Primary Outcomes

Change in knowledge about type 1 diabetes

Time Frame: 6 months from intervention

Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)

Secondary Outcomes

  • Change in diabetes self-care practices(at 3 months and 6 months)
  • Change in percent of blood glucoses high, in range and low(at 3 months and 6 months)
  • Percent of text messages responded to in the study.(After 6 months of texting intervention)
  • Change in Hemoglobin A1c(at 3 months and 6 months)
  • Change in blood glucose testing frequency(at 3 months and 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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