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临床试验/NCT03032744
NCT03032744
已完成
不适用

Aligning With Schools To Help Manage Asthma

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 29 人2017年1月17日

概览

阶段
不适用
干预措施
Asthma Assessment & Management
疾病 / 适应症
Asthma
发起方
State University of New York at Buffalo
入组人数
29
试验地点
1
主要终点
Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up
状态
已完成
最后更新
2个月前

概览

简要总结

Project ASTHMA is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among children from communities with health disparities.

详细描述

Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All students will receive NHLBI guideline-based asthma assessments to determine eligibility and proper dosing of preventive medication. The asthma assessment will include spirometry testing. All enrolled students and parents will receive asthma education at the time of enrollment. Eligible students will be randomized to an intervention or usual care group using permuted block randomization stratified by SBHCs. In collaboration with the student's PCP, the SBHCs' mid-level providers will prescribe the preventive medication to the students in the intervention group. These students will receive the morning dose of their preventive medication from the school nurse each school day for the remainder of the school year. Students and their parents will be responsible to administer the evening and non-school day doses. Students randomized to the usual care group will be referred back to their PCP for further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after enrollment, and medication dose adjustments will be made in the intervention group as needed.

注册库
clinicaltrials.gov
开始日期
2017年1月17日
结束日期
2020年6月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Lucy Holmes, MD

Clinical Associate Professor of Pediatrics

State University of New York at Buffalo

入排标准

入选标准

  • Active asthma
  • Diagnosed with asthma for at least 12 months
  • Enrolled in the school-based health center
  • Persistent asthma as defined by NAEPP-EPR3 guidelines OR at least 1 hospitalizations OR at least 2 ED/urgent care visits OR at least 2 courses of oral steroids for asthma in the previous 12 months for asthma

排除标准

  • Underlying heart or lung disease other than asthma
  • Student has well controlled asthma

研究组 & 干预措施

Intervention

All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days.

干预措施: Asthma Assessment & Management

Intervention

All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days.

干预措施: Asthma Education

Intervention

All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days.

干预措施: Controller medication at school

Usual Care

All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.

干预措施: Asthma Assessment & Management

Usual Care

All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.

干预措施: Asthma Education

结局指标

主要结局

Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up

时间窗: Baseline, 1-month, 3-month, 5-month, 7-month

Total number of days per week, over the previous 4 weeks, of asthma symptoms Minimum: 0 Maximum: 7 Lower number indicates improvement The change in number of days per week of asthma symptoms from baseline to 7-month follow-up

次要结局

  • Change in ACT Score From Baseline to 7-month Follow-up(Baseline, 1-month, 3-month, 5-month, 7-month)
  • Change in FEV1/FVC Ratio From Baseline to 7-month Follow-up(Baseline, 1-month, 3-month, 5-month, 7-month)

研究点 (1)

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