跳至主要内容
临床试验/NCT01891773
NCT01891773已完成不适用

Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)

Children's National Research Institute0 个研究点目标入组 48 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
主要终点
Proportion of doses received

研究概览

简要总结

Asthma is the most common chronic pediatric disease in the United States, and is the most common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged minority children receive disproportionately poor asthma care and incur a disproportionate share of asthma-related morbidity. The District of Columbia is particularly severely affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of 22%, more than double the national average.

One of the major challenges in treating asthma is poor adherence to daily controller medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH guidelines for asthma management. In an attempt to overcome poor compliance, investigators in Rochester, New York have partnered with primary care providers in their community to arrange for ICS administration at school by school nurses, and this approach yielded significant improvements in several asthma outcomes.

The investigators propose to collaborate in a pilot research project with the overall goal of improving asthma outcomes through reducing barriers to medication adherence. Specifically, the investigators aim to improve adherence to controller medications (inhaled corticosteroids - ICS) among DC children with asthma through the following activities:

  1. A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma.
  2. Qualitative interviews with nurses from DC public and public charter school to identify key barriers to administration of daily controller medications in the school setting

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
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current enrollment in one of the grades K-8 at a DC public school (DCPS) or DC public charter school (DCPCS)
  • Active public insurance
  • Persistent asthma
  • An Asthma Action Plan including daily ICS
  • Child's primary asthma caregiver present, meaning the person who usually takes care of his/her asthma at home and can answer questions about his/her medical history.

排除标准

  • Chronic disease of the cardio-pulmonary system other than asthma
  • Non-English speaking parent/guardian
  • Currently enrolled in in another asthma study

结局指标

主要结局

Proportion of doses received

时间窗: 60 day treatment period

Proportion of doses of ICS received during the 60 days outcome period

次要结局

未报告次要终点

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen J. Teach, MD, MPH

Associate Chief, Division of Emergency Medicine

Children's National Research Institute

相似试验

Improving Pediatric Asthma Care Through Inhaled... | 临床试验