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

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

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 Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Texting

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 800045
      • Barbara Davis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Texting; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge about type 1 diabetes	Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)	6 months from intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Hemoglobin A1c		at 3 months and 6 months
Change in blood glucose testing frequency		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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Sonalee Ravi, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: adolescent; young adult; knowledge; self-care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 17-1135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No