Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Change in glycemic control from baseline to 1 year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Teenwork Group
Teen/family will receive the Teenwork intervention at each quarterly study visit.
干预措施: Teenwork intervention (Behavioral)
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.
干预措施: Teenwork intervention (Behavioral)
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.
干预措施: Text message reminders (Behavioral)
Text Message Group
Teen will receive text message reminders to check blood glucose levels at self-selected times.
干预措施: Text message reminders (Behavioral)
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.
结局指标
主要结局
Change in glycemic control from baseline to 1 year
时间窗: Baseline and 1 year
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
次要结局
- Change in glycemic control from 1 year to 18 months(1 year and 18 months)
- Psychosocial factors (self-report surveys)(Baseline, 6 months, 1 year, 18 months)
研究者
Lori Laffel
Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section
Joslin Diabetes Center