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临床试验/NCT01997463
NCT01997463已完成4 期

The Cost Effectiveness of School-Based Supervised Asthma Therapy

University of Arizona1 个研究点 分布在 1 个国家目标入组 442 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
442
试验地点
1
主要终点
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)

研究概览

简要总结

The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.

详细描述

This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.

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
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • A child with asthma attending a Tucson Unified School District elementary school selected for the study.

排除标准

  • No asthma.
  • Not attending a Tucson Unified School District elementary school selected for the study.

研究组 & 干预措施

Supervised Therapy

Experimental

Supervised asthma therapy in schools

干预措施: Supervised asthma therapy in schools (Drug)

结局指标

主要结局

The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)

时间窗: 1 year

An ACQ score of \> 1.5 means asthma is not well controlled. An ACQ score of \<= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ

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 (1)

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