Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)
Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)
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:
- A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma.
- 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
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Chronic disease of the cardio-pulmonary system other than asthma
- Non-English speaking parent/guardian
- Currently enrolled in in another asthma study
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：School-based therapy
Daily dose of medication to be provided in the school setting.
|
Morning dose of inhaled steroids given in school by school nurse instead of at home.
|
|
无干预：Usual Care
Daily medication to be taken at home.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of doses received
大体时间：60 day treatment period
|
Proportion of doses of ICS received during the 60 days outcome period
|
60 day treatment period
|
合作者和调查者
调查人员
- 首席研究员：Stephen Teach, MD, MPH、Children's National Research Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.