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

Study Overview
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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.

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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Teenwork intervention
* Behavioral: Text message reminders


Participation Criteria
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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 At least one clinic visit at the clinical site in the previous 12 months 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teenwork Group<br>Teen/family will receive the Teenwork intervention at each quarterly study visit. | Behavioral: Teenwork intervention<br>* Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration<br>|
| Experimental: Teenwork/Text Message Group<br>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. | Behavioral: Teenwork intervention<br>* Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration<br>Behavioral: Text message reminders<br>* Text message reminders to check blood glucose levels at self-selected times<br>|
| Experimental: Text Message Group<br>Teen will receive text message reminders to check blood glucose levels at self-selected times. | Behavioral: Text message reminders<br>* Text message reminders to check blood glucose levels at self-selected times<br>|
| No Intervention: Usual Care Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic control from baseline to 1 year | Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%) | Baseline and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic control from 1 year to 18 months | Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%) | 1 year and 18 months | 
| Psychosocial factors (self-report surveys) | We will assess psychosocial factors (e.g., diabetes-specific family conflict, diabetes burden, negative affect around blood glucose monitoring, quality of life, depressive symptoms, self-efficacy, disordered eating behaviors) every 6 months | Baseline, 6 months, 1 year, 18 months |