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临床试验/NCT01286350
NCT01286350已完成不适用

FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
258
试验地点
4
主要终点
Hemoglobin A1c

研究概览

简要总结

The purpose of this study is to see if a behavioral intervention for adolescents with type 1 diabetes will improve adherence to T1D self-management activities and improve diabetes outcomes. We expect the intervention to improve diabetes outcomes when compared to usual care.

详细描述

The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support.

All FL3X intervention participants will receive "FL3X-Basic", which is the initial 3-month intervention that includes 4 sessions (40-60 min), supplemented with short additional contacts (via text, email, or web-based communication) as needed. Thereafter, applying principles of adaptive interventions, based on a decision rule using A1c values measured at defined intervals, participants are iteratively assigned to "FL3X-Check-in" or "FL3X-Regular", both of which continue with MI and PSST for the underlying counseling strategy. In FL3X-Check-in, participants who are doing well ("responders") will receive minimal ongoing support to reinforce successful strategies through brief monthly "touch-base" contacts. In FL3X-Regular, those who are "Regular-responders" will have a minimum of 3-4 in-person full-length sessions (40-60 min) over each 6-month interval, with additional brief contacts as needed (e.g., text, voice, or internet). FL3X participants randomized to the control group will receive usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • type 1 diabetes with duration at least 12 months
  • between ages 12-16 years at registration
  • poor glycemic control (A1c 8.0-13.0%)
  • parent/guardian willing to also participate
  • not planning on moving in the following 18 months

排除标准

  • pregnant (if female)
  • diabetes type 2 or gestational
  • Pre-existing systemic chronic disease (drug abuse, cancer, certain psychiatric conditions)

结局指标

主要结局

Hemoglobin A1c

时间窗: 0, 3, 6, 12, 18, 24, 30 months

HbA1c will be measured to determine impact on glucose control

次要结局

  • Problem solving skills(0, 3, 6, 12, 18, 24, 30 months)
  • Diabetes self-management behaviors(0, 3, 6, 12, 18, 24, 30 months)
  • Motivation(0, 3, 6, 12, 18, 24, 30 months)
  • Risk factors for diabetes complications(0, 3, 6, 12, 18, 24, 30 months)
  • Hypoglycemia(0, 6, 18 mo)
  • Health-related quality of life(0, 3, 6, 12, 18, 24, 30 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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