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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teenwork Group

Teen/family will receive the Teenwork intervention at each quarterly study visit.

Group Type EXPERIMENTAL

Teenwork intervention

Intervention Type BEHAVIORAL

Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration

Teenwork/Text Message Group

Teen/family will receive the Teenwork intervention at each quarterly study visit. Teen will receive text message reminders to check blood glucose levels at self-selected times.

Group Type EXPERIMENTAL

Teenwork intervention

Intervention Type BEHAVIORAL

Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration

Text message reminders

Intervention Type BEHAVIORAL

Text message reminders to check blood glucose levels at self-selected times

Text Message Group

Teen will receive text message reminders to check blood glucose levels at self-selected times.

Group Type EXPERIMENTAL

Text message reminders

Intervention Type BEHAVIORAL

Text message reminders to check blood glucose levels at self-selected times

Usual Care Group

Teen/family will receive routine clinical care for the first year of the study (the time period for assessment of primary outcomes). After year 1, teen/family will receive the Teenwork intervention at each remaining study visit and teen will receive text message reminders to check blood glucose levels at self-selected times.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Teenwork intervention

Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration

Intervention Type BEHAVIORAL

Text message reminders

Text message reminders to check blood glucose levels at self-selected times

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Youth age 13-17 years
* Diagnosis of type 1 diabetes according to American Diabetes Association criteria
* Diabetes duration ≥6 months
* Daily insulin dose ≥0.5 units/kg
* A1c ≥6.5%and ≤11%
* Willingness to check blood glucose levels
* Cell phone with text messaging ability
* Clinic attendance

1. At least one clinic visit at the clinical site in the previous 12 months
2. Anticipated care at the clinical site for the duration of the study
* Fluency in English (reading, writing, and speaking) for child and parent/guardian
* Enrollment no later than December of the teen's senior year of high school

Exclusion Criteria

* Pregnancy in the youth participant
* Significant developmental or cognitive disorder that would prevent full study participation
* Significant mental illness, defined by either major psychiatric disorder (e.g., diagnosed eating disorder, major psychoses) or inpatient psychiatric admission within the previous 6 months
* Failure to understand that the 2-way text messaging does NOT result in immediate response from a health care professional; this will be assessed at the time of informed consent/assent
* Participation in another intervention study within the 3 months prior to enrollment
* Other psychosocial, medical, or family issues, as assessed by the teen's pediatric team, that would prevent full study participation

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No