Adherence to IDDM Regimen in Urban Youth
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
- 否
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
Deborah Ellis, Ph.D.
Professor
Wayne State University
