Aligning With Schools To Help Manage Asthma (Project ASTHMA)

Aligning With Schools To Help Manage Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Asthma Assessment & Management; Other: Asthma Education; Other: Controller medication at school

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • John R. Oishei Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Asthma Assessment & Management; Asthma Assessment & Management based on NAEPP-EPR3 guidelines; Other: Asthma Education; Asthma education on medications; Other: Controller medication at school; Students will receive the morning dose of their daily preventive asthma medication at school on school days.
Active Comparator: 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.	Other: Asthma Assessment & Management; Asthma Assessment & Management based on NAEPP-EPR3 guidelines; Other: Asthma Education; Asthma education on medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Asthma Symptoms	decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ACT Score	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.	7 months
Change in Lung function	improvement in spirometry	7 months
Change in ED/urgent care visits	Decrease in ED/urgent care visits	2 years
Change in Hospitalizations	Decrease in hospitalizations	2 years
Change in Oral/parenteral steroid use	Decrease in oral/parenteral steroid use	2 years
Change in Missed days of school	decrease in missed days of school	2 years

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Lucy C Holmes, MD, MPH, University at Buffalo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimated): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric; School Based Health Center
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: IMPACT1; UL1TR001412 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No