Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 13 - 17 |
Updated: | 1/11/2019 |
Start Date: | November 2013 |
End Date: | August 2016 |
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.
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.
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.
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.
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
We found this trial at
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Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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