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临床试验/NCT02547311
NCT02547311已完成不适用

Shared Medical Appointments to Improve Outcomes in Adolescents With Type 1 Diabetes

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2012年10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
318
试验地点
2
主要终点
Satisfaction Questionnaire

研究概览

简要总结

Adolescents and emerging adults with type 1 diabetes (T1D) experience significant struggles with their diabetes management resulting in worsening diabetes health and increased complications. This population's declining well-being occurs during a time when they should be at their healthiest and enjoying multiple exciting life transitions. Their worsening diabetes management is complicated by the fact they are also learning how to become more independent from their family in preparation for eventually leaving home. Furthermore, the number of people under 20 years of age diagnosed with T1D has increased dramatically over the past 10 years giving rise to increased concern about providing care to this population.

The Team Clinic Intervention is an innovative clinical care approach to address the medical and developmental needs of adolescents with T1D and their families. A group medical appointment format will be used for routine diabetes clinic visits in middle school and high school adolescents with T1D. Parents of these patients will be participating in their own group during these clinic visits. The Team Clinic model incorporates developmentally tailored peer support and novel learning tools, (e.g. games, physical activity, and/or interaction through Internet resources, e.g. blogs, forums) into the shared medical appointment design.

The goal of Team Clinic Intervention is to improve medical and psychological outcomes in adolescents with T1D and their parents. The study will investigate, in a randomized controlled trial, the efficacy of a novel clinical care model that addresses the unique developmental strengths and weaknesses of the T1D adolescent population. The Team Clinic format streamlines clinical care delivery to this often-challenging patient population without placing additional burden on youth, families, or clinics because the intervention will be completed during routine diabetes care visits. Moreover, the Team Clinic approach maximizes the benefits of peer support by delivering care in a group format to address the sense of isolation that teens and families coping with chronic illness often feel.

If successful, the Team Clinic Intervention will not only positively impact adolescents with T1D and their families, but it could be used as a model of care for other adolescents with chronic medical conditions struggling to remain involved and invested in their medical care. Team Clinics may be one approach to successfully engaging adolescents in their diabetes care prior to their transition away from home, which will help them remain invested and active in their medical care through adolescence and young adulthood.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • T1D >1 year duration, 6th-10th grade

排除标准

  • non-English speaking
  • severe behavioral, developmental, or psychological diagnosis making group participation difficult

结局指标

主要结局

Satisfaction Questionnaire

时间窗: 30 months

Clinic satisfaction (patient and parent)

Glycemic control

时间窗: 30 months

Hemoglobin A1c

Diabetes distress Questionnaire

时间窗: 30 months

Diabetes distress (patient and parent)

Cost effectiveness

时间窗: 30 months

Clinical cost effectiveness of intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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