Aligning With Schools To Help Manage Asthma (Project ASTHMA)

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT03032744
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-01-17
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Primary Completion: 2019-07
• Study Completion: 2020-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Asthma Symptoms	7 months	decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score

Secondary Outcome Measures

Name	Time	Method
Change in ED/urgent care visits	2 years	Decrease in ED/urgent care visits
Change in Missed days of school	2 years	decrease in missed days of school
Change in ACT Score	7 months	Improvement in ACT score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control.
Change in Hospitalizations	2 years	Decrease in hospitalizations
Change in Oral/parenteral steroid use	2 years	Decrease in oral/parenteral steroid use
Change in Lung function	7 months	improvement in spirometry

Trial Locations

Locations (1)

John R. Oishei Children's Hospital; 🇺🇸 Buffalo, New York, United States