跳至主要内容
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2006年8月
适应症Asthma

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Asthma
发起方
University of Rochester
入组人数
530
试验地点
1
主要终点
Number of Symptom Free Days
状态
已完成
最后更新
11年前

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.

注册库
clinicaltrials.gov
开始日期
2006年8月
结束日期
2012年1月
最后更新
11年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Jill Halterman

Associate Professor of Pediatrics

University of Rochester

入排标准

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

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))

研究点 (1)

Loading locations...

相似试验