Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting

Type 1 Diabetes Mellitus Clinical Trial

— ASKED-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241212
• Other study ID #: 17-1135
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: May 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of type 1 diabetes mellitus

2. Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)

3. Age 15-20 at study enrollment

4. English literate and English speaking

5. Ability to complete the required surveys

6. Have a personal cell phone with service compatible with EZTexting Platform

7. Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).

Exclusion Criteria:

1. Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.

2. Diabetes Diagnosis other than Type 1 Diabetes

3. Inability for the adolescent to respond to text messages (e.g. due to developmental delay)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Texting
From baseline appointment to 6 month follow up, those participants randomly assigned to the texting intervention 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.

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knowledge about type 1 diabetes	Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)	6 months from intervention
Secondary	Change in diabetes self-care practices	Assessed by the Self-Management of Type 1 Diabetes in Adolescents (SMOD-A) tool	at 3 months and 6 months
Secondary	Change in Hemoglobin A1c		at 3 months and 6 months
Secondary	Change in blood glucose testing frequency		at 3 months and 6 months
Secondary	Change in percent of blood glucoses high, in range and low		at 3 months and 6 months
Secondary	Percent of text messages responded to in the study.		After 6 months of texting intervention