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临床试验/NCT01175369
NCT01175369已完成不适用

School-Based Asthma Therapy: Stage 2 Effectiveness Study

University of Rochester1 个研究点 分布在 1 个国家目标入组 530 人开始时间: 2006年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
530
试验地点
1
主要终点
Number of Symptom Free Days

研究概览

简要总结

Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Physician-diagnosed asthma
  • •Mild persistent to severe persistent asthma
  • •Ages 3-10 years
  • •Attending school in the Rochester City School District preschools or elementary schools
  • •Signed physician permission to enroll the child
  • •Parent or caregiver must consent to the intervention

排除标准

  • •Inability to speak and understand either English or Spanish
  • •No access to a working phone for follow-up surveys
  • •The family planning to leave the school district within fewer than 6 months
  • •The child having other significant medical conditions that could interfere with the assessment of asthma-related outcome measures
  • •children in foster care or other situations in which consent cannot be obtained from a guardian
  • •Current participation in other local asthma interventions

研究组 & 干预措施

Usual Care

No Intervention

Usual asthma care

School-based Care

Experimental

The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).

干预措施: School-based Care (Behavioral)

结局指标

主要结局

Number of Symptom Free Days

时间窗: Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)

The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).

次要结局

  • Cotinine Level(2 month and approximately 9 month (end of school year) follow-up assessments)
  • Cost Effectiveness of the Intervention(approximately 9 months (length of school year))
  • Additional Asthma Morbidity Outcomes(1-9 months (Monthly Follow-up assessments))

研究者

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

Jill Halterman

Associate Professor of Pediatrics

University of Rochester

研究点 (1)

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