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临床试验/NCT00519935
NCT00519935已完成不适用

Adherence to IDDM Regimen in Urban Youth

Wayne State University2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2001年7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
127
试验地点
2
主要终点
Metabolic Control: Hemoglobin A1c (HbA1c)

研究概览

简要总结

The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an intensive home-based family psychotherapy intervention, to a group of urban adolescents with poorly controlled Type 1 diabetes and their families.

详细描述

Substantial data exists to demonstrate that improving metabolic control in persons with Type 1 diabetes mellitus (T1DM) can delay the onset of diabetes complications and reverse some existing complications as well. Unfortunately, those adolescents with T1DM who are at highest risk for diabetes complications are often the most resistant to hospital based care and traditional education/ supportive interventions. They are also faced with multiple barriers to improved metabolic control, which may include lack of knowledge about diabetes, family disorganization and disengagement, high levels of stress and an unhealthy lifestyle. Multisystemic Therapy (MST), a flexible and home-based therapeutic intervention originally designed for use with mental health populations, seems to be a promising approach to providing diabetic adolescents with the ability to engage in consistent and attentive illness management.

The study recruited a sample of 127 adolescents in poor metabolic control and randomly assigned them to either the treatment intervention, MST plus standard medical care, or standard medical care alone. Families randomized to MST received intensive, home-based family therapy for approximately six months. Families completed data collection at baseline and then again at 7, 12 18 and 24 months after study entry.

研究设计

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

入排标准

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

入选标准

  • a current hemoglobin A1c(HbA1c) of >8.0%
  • an average HbA1c of >8.0% during the past year
  • diagnosed with Type 1 diabetes for at least one year
  • reside in the metro Detroit tri-county area

排除标准

  • severe mental impairment/thought disorder
  • non-English speaking patient/parent
  • co-morbid major medical condition such as cystic fibrosis

结局指标

主要结局

Metabolic Control: Hemoglobin A1c (HbA1c)

时间窗: 2 years

Retrospective measure of blood glucose control, encompasses the previous 2-3 months

次要结局

  • Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads(2 years)
  • DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)(2 years)
  • Quality of life(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah Ellis, Ph.D.

Professor

Wayne State University

研究点 (2)

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