Clinical trial NCT03032744: Aligning With Schools To Help Manage Asthma (Project ASTHMA)
Official title: Aligning With Schools To Help Manage Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Pediatric
School Based Health Center
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-01-26
Enrollment: 29
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student \& family will be responsible to administer the evening dose \& both doses on non-school days.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Asthma Symptoms
timeFrame: 7 months
Secondary outcomes:
measure: Change in ACT Score
timeFrame: 7 months
measure: Change in Lung function
timeFrame: 7 months
measure: Change in ED/urgent care visits
timeFrame: 2 years
measure: Change in Hospitalizations
timeFrame: 2 years
measure: Change in Oral/parenteral steroid use
timeFrame: 2 years
measure: Change in Missed days of school
timeFrame: 2 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: John R. Oishei Children's Hospital
state: New York
Study officials:
affiliation: University at Buffalo
name: Lucy C Holmes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmes LC, Orom H, Lehman HK, Lampkin S, Halterman JS, Akiki V, Supernault-Sarker AA, Butler SB, Piechowski D, Sorrentino PM, Chen Z, Wilding GE. A pilot school-based health center intervention to improve asthma chronic care in high-poverty schools. J Asthma. 2022 Mar;59(3):523-535. doi: 10.1080/02770903.2020.1864823. Epub 2021 Jan 6.