Aligning With Schools To Help Manage Asthma (Project ASTHMA)

University at Buffalo (UB)

Status: Completed

Conditions: Asthma

Treatments: Other: Asthma Education; Other: Controller medication at school; Other: Asthma Assessment & Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03032744

IMPACT1

UL1TR001412 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Asthma Education

Other: Asthma Assessment & Management

Other: Controller medication at school

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Asthma Education

Other: Asthma Assessment & Management