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
- 146
- 试验地点
- 2
- 主要终点
- Metabolic Control: Hemoglobin A1c (HbA1c)
研究概览
简要总结
The study is a randomized clinical trial testing the effectiveness of Multisystemic Therapy (MST) for improving the treatment adherence, metabolic control and quality of life of urban adolescents with poorly controlled insulin dependent diabetes.
详细描述
The deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. However, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (CPMC) and post-diagnostic admissions for diabetic ketoacidosis (DKA). Adolescents in CPMC represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. Minority and low-income children are over-represented among adolescents with CPMC.
The design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive MST and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). Subjects must have a current hemoglobin A1C (HbA1c) of >8% and an average HbA1c of >8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro Detroit tri-county area. Exclusion criteria are severe mental impairment/thought disorder, non-English speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. Families who are randomized to MST receive intensive, home-based family therapy for approximately six months. MST is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. Therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •insulin dependent Type 1 or Type 2 diabetes
- •diagnosed with diabetes ≥ 1 year
- •current HbA1c ≥ 8%
- •average HbA1c ≥ 8% over the past year
- •aged 10 -17
- •patient of Children's Hospital of Michigan Diabetes Clinic
- •lives within 30 miles of Children's Hospital of Michigan
排除标准
- •moderate to severe mental retardation (unable to complete study measures)
- •psychosis or current suicidal intent
- •any medical diagnosis that alters standard diabetes care
结局指标
主要结局
Metabolic Control: Hemoglobin A1c (HbA1c)
时间窗: treatment termination, 6-month follow up
Retrospective measure of blood glucose control, encompasses the previous 2-3 months
次要结局
- BMI percentile(treatment termination, 6-month follow up)
- Diabetes-Specific Family Functioning(treatment termination, 6-month follow up)
- DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)(treatment termination, 6-month follow up)
- Regimen Adherence: Diabetes Management Scale (DMS), Twenty-Four Hour Recall Interview, Glucose Meter Downloads(treatment termination, 6-month follow up)
研究者
Deborah Ellis, Ph.D.
Professor of Pediatrics
Wayne State University
