Pollution Intervention to Impact Kids Asthma Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Change in asthma control scores, over-time, between groups
研究概览
简要总结
The goal of this clinical trial is to learn if adding Air Quality Index (AQI) information to asthma action plans works to improve asthma outcomes in children. It will also learn about children with asthma who report being more sensitive to outdoor air pollution. The main questions it aims to answer are:
- Does adding either information about the EPA-AQI or commercial AQI improve asthma outcomes over time?
- Are there changes in nasal gene expression in children with asthma who report they are more sensitive to outdoor air pollution?
Researchers will compare EPA-AQI and the commercial-AQI groups to a control group to either AQI works to improve asthma.
Participants will:
- Receive standardized outdoor air pollution education and an asthma action plan
- Provide nose and blood specimens
- Have visits every 4 weeks for 48 weeks, 10 will be conducted by telephone calls and 3 visits will be in person.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A healthcare provider diagnosis of persistent asthma (Steps 2-5 as defined by US guidelines) or intermittent asthma (Step 1) + at least one severe asthma exacerbation (defined by American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria as requiring at least 3 days of systemic steroids or an Emergency Department/Urgent Care visit requiring systemic steroids) in the prior 12 months
- •Home access to a smartphone or internet
- •Primary residence in Allegheny County, PA
- •One participant per household
- •Age 8 -17 years
- •Healthcare provider evaluation for asthma in the prior year
排除标准
- •Diagnosis of other active chronic respiratory diseases (e.g., cystic fibrosis, bronchopulmonary dysplasia, etc.)
- •Neuromuscular disorder
- •Chronic disorder limiting independent ambulation (e.g., spastic quadriplegia, etc.)
- •Cyanotic heart disease
- •Plans to relocate from Allegheny County, PA in the next year (12 months)
- •Use of intranasal or oral/intramuscular/intravenous corticosteroids 4 weeks prior to randomization
- •Current participation in another asthma intervention trial
研究组 & 干预措施
Control (Standard outdoor air pollution education + asthma action plan)
Control
干预措施: Education and plan (Behavioral)
EPA-AQI (Education+ plan + EPA-AQI)
EPA-AQI
干预措施: EPA-AQI (Behavioral)
EPA-AQI (Education+ plan + EPA-AQI)
EPA-AQI
干预措施: Education and plan (Behavioral)
Commercial-AQI (Education+ plan + commercial-AQI)
Commercial-AQI
干预措施: Commerical-AQI (Behavioral)
Commercial-AQI (Education+ plan + commercial-AQI)
Commercial-AQI
干预措施: Education and plan (Behavioral)
结局指标
主要结局
Change in asthma control scores, over-time, between groups
时间窗: Baseline through 48 weeks, measured at 4 week intervals
Asthma control will be measured via the validated Asthma Control Test (ACT) and Childhood-ACT (CACT). Asthma control will be evaluated at all study visits (Visits 1-13), every 4 weeks. The ACT will be used for children aged 12 -17 years, the CACT will be used for children aged 8-11 years. The ACT is a 5 question instrument with scores from 5-25, with higher scores generally indicating better control. The CACT is a 7 question instrument with scores from 0-27, with higher scores generally indicating better control. For both ACT and CACT, scores of 19 or less are concerning for poor asthma control and both measure control in the past 4 weeks.
次要结局
- Change in Pediatric Asthma Quality of Life (PAQLQ) score over-time between groups(Baseline through 48 weeks, measured at Visit 1 (time=0), Visit 7 (time=24 weeks), and Visit 13 (time=48 weeks).)
- Severe asthma exacerbations, having at least one, over-time between groups(Baseline through 48 weeks, measured at 4 week intervals)
研究者
Franziska Rosser, MD MPH
Assistant Professor
University of Pittsburgh