Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Asthma exacerbations
研究概览
简要总结
Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •uncontrolled asthma
排除标准
- •other chronic lung disease such as cystic fibrosis
研究组 & 干预措施
PCP group
SBHC group
干预措施: APP assessment and management of asthma (Other)
结局指标
主要结局
Asthma exacerbations
时间窗: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Number of asthma exacerbations requiring systemic steroids based on medical records
次要结局
- Spirometry - FEV1(to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year)
- ED visits(from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.)
- Quality of Life - caregiver(to be assessed at baseline and at 7-month follow-up for 1 school year)
- Daytime asthma symptoms(to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year)
- Spirometry - FEV1/FVC ratio(to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year)
- Nighttime asthma symptoms(to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year)
- Hospitalizations(from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.)
- Activity Limitation(to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year)
- Urgent care visits(from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.)
- school absenteeism(from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.)
研究者
Lucy Holmes, MD
Clinical Associate Professor of Pediatrics
State University of New York at Buffalo