Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)
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:
- 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
- 否
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
Stephen J. Teach, MD, MPH
Associate Chief, Division of Emergency Medicine
Children's National Research Institute
