Project ASTHMA - Aligning With Schools To Help Manage Asthma and Improve Outcomes

January 20, 2026 updated by: Lucy Holmes, MD, State University of New York at Buffalo

Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities

Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo, Department of Pediatrics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • uncontrolled asthma

Exclusion Criteria:

  • other chronic lung disease such as cystic fibrosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBHC group
Other: APP assessment and management of asthma
APPs will be trained to follow NIH guidelines for assessment and management of asthma, and to apply their knowledge to the care of the students. Students will also receive DOT of the morning dose of their controller medication.
Other Names:
  • DOT of morning dose of controller medication
No Intervention: PCP group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma exacerbations
Time Frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Number of asthma exacerbations requiring systemic steroids based on medical records
from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry - FEV1
Time Frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Forced Expiratory Volume in 1 second
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Spirometry - FEV1/FVC ratio
Time Frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
FEV1/Forced Vital Capacity ratio
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
ED visits
Time Frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Number of ED visits for asthma symptoms based on medical records
from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Urgent care visits
Time Frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Number of urgent care visits for asthma symptoms based on medical records
from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Hospitalizations
Time Frame: from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.
Number of hospitalizations based on medical records
from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.
school absenteeism
Time Frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Number of missed school days based on school records
from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Daytime asthma symptoms
Time Frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Frequency of daytime asthma symptoms based on questionnaire minimum value: 0 days maximum value: 28 days Higher scores mean a worse outcome.
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Nighttime asthma symptoms
Time Frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Frequency of nighttime asthma symptoms based on questionnaire minimum value: 0 nights maximum value: 28 nights Higher scores mean a worse outcome.
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Quality of Life - caregiver
Time Frame: to be assessed at baseline and at 7-month follow-up for 1 school year
Children's Health Survey for Asthma, American Academy of Pediatrics Higher scores mean a better outcome.
to be assessed at baseline and at 7-month follow-up for 1 school year
Activity Limitation
Time Frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Degree of activity limitation based on questionnaire Higher scores mean a worse outcome.
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007712
  • R01MD018384 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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