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

NCT03241212 | Completed

• 1 other identifier: 17-1135
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

adolescent; young adult; knowledge; self-care

Outcome Measures

Primary Outcomes (1)

• Change in knowledge about type 1 diabetes

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

  6 months from intervention

Secondary Outcomes (5)

• Change in diabetes self-care practices

  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

Study Arms (2)

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.

Behavioral: Texting

Interventions

Texting BEHAVIORAL

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.

Texting

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 800045, 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

Study Officials

• Sonalee Ravi, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: September 12, 2017
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)