School-based Approaches to Help Pre-teens Manage Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,292
- 主要终点
- Health Care Use Data
研究概览
简要总结
This random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, African American students in middle schools in Detroit, MI. The goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes, and 2) if the program, enhanced by a peer component, improves upon outcomes. Outcomes of interest are symptom experience, quality of life, self-management, and school grades.
详细描述
BACKGROUND:
To date, no data provide information on the effects of middle school based interventions for pre-teens with asthma or the advantages of an approach that recognizes the importance of peer influence on pre-teen's asthma behavior. Interventions to reach low income minority populations are particularly needed.
DESIGN NARRATIVE:
If only one primary outcome is to be specified, it would be asthma morbidity, as evident in asthma symptoms. Data to assess outcomes will be collected at baseline, and 12 and 24 months post program through parent interviews and student surveys.
Additional primary outcomes listed in the protocol include: Asthma related quality of life, disease management behavior and academic performance.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 11 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Health Care Use Data
时间窗: At Baseline, 12 month and 24 months
health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.
次要结局
未报告次要终点
研究者
Noreen M. Clark
Principal Investigator
University of Michigan