Aligning With Schools To Help Manage Asthma (Project ASTHMA)

NCT ID: NCT03032744

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2020-06-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Asthma Assessment & Management

Intervention Type: OTHER

Asthma Assessment \& Management based on NAEPP-EPR3 guidelines

Asthma Education

Intervention Type: OTHER

Asthma education on medications

Controller medication at school

Intervention Type: OTHER

Students will receive the morning dose of their daily preventive asthma medication at school on school days.

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.

Group Type: ACTIVE_COMPARATOR

Asthma Assessment & Management

Intervention Type: OTHER

Asthma Assessment \& Management based on NAEPP-EPR3 guidelines

Asthma Education

Intervention Type: OTHER

Asthma education on medications

Interventions

Asthma Assessment & Management

Asthma Assessment \& Management based on NAEPP-EPR3 guidelines

Intervention Type: OTHER

Asthma Education

Asthma education on medications

Intervention Type: OTHER

Controller medication at school

Students will receive the morning dose of their daily preventive asthma medication at school on school days.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Lucy Holmes, MD

Clinical Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucy C Holmes, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

John R. Oishei Children's Hospital

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33322963 (View on PubMed)

Other Identifiers

UL1TR001412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMPACT1

Identifier Type: -

Identifier Source: org_study_id