Clinical Trials Directory

Trials / Completed

CompletedNCT01892280

Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
310 (actual)
Sponsor
Joslin Diabetes Center · Academic / Other
Sex
All
Age
13 Years – 17 Years
Healthy volunteers
Not accepted

Summary

The purpose of this 18-month randomized controlled trial (RCT) is to find out if (1) a set of psychoeducational materials for teens with type 1 diabetes and (2) text message reminders to check blood glucose levels can help improve blood glucose levels in teens with type 1 diabetes.

Detailed description

Glycemic control deteriorates during adolescence as parents become less involved in teens' diabetes management and adherence declines. Thus, there is a need to improve adherence and glycemic control in mid to older teens with type 1 diabetes by strengthening the teens' self-efficacy for daily diabetes self-management to help prepare them for the transition between pediatric and adult care. This 18-month, multi-center RCT is designed to increase frequency of blood glucose monitoring and improve glycemic control in teens with type 1 diabetes through a behavioral intervention called Teenwork with or without text message reminders to check blood glucose levels. We will implement and evaluate the Teenwork intervention and text message reminders to check blood glucose levels in a 2x2 factorial design in which 300 participants, across two sites, will be randomized to 1 of 4 groups: Teenwork, Text Message, Teenwork/Text Message, or Usual Care. Participants in the Teenwork Group will meet with a research assistant during each study visit to review strategies for improving self-care, including self-management and self-advocacy, focusing on two areas: blood glucose monitoring and insulin administration. Participants in the Text Message Group will be instructed in the use of the text messaging system. They will receive 2-way text message reminders to check blood glucose levels at self-selected times and to reply by text message with blood glucose results. Participants in the Teenwork/Text Message Group will receive both the Teenwork intervention and the text message reminders (as described above). Participants in the Usual Care Group will receive the same intervention as the Teenwork/Text Message Group, but not until after 1 year.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTeenwork interventionSet of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
BEHAVIORALText message remindersText message reminders to check blood glucose levels at self-selected times

Timeline

Start date
2013-11-01
Primary completion
2016-02-01
Completion
2016-08-01
First posted
2013-07-04
Last updated
2021-08-10

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01892280. Inclusion in this directory is not an endorsement.