Recruiting

Asthma Management

Sponsor:

State University of New York at Buffalo

Code:

NCT06539312

Conditions

Asthma in Children

Directly Observed Therapy

Eligibility Criteria

Sex: All

Age: 4 - 13

Healthy Volunteers: Not accepted

Interventions

APP assessment and management of asthma

Study Details

Brief summary:

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.

Conditions

Asthma in Children

Directly Observed Therapy

Study ID

NCT06539312

Start date

Sep 27, 2024

Status verified date

Jun, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 13

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • uncontrolled asthma

Exclusion Criteria:

  • other chronic lung disease such as cystic fibrosis

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: SBHC group

no intervention: PCP group

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Lucy CY Holmes, MD, MPH

716-323-0034LHolmes@upa.chob.edu

Deanna Hamilton, MSEd

716-323-0060DeHamilton@upa.chob.edu

Locations

University at Buffalo, Department of Pediatrics

Recruiting

Buffalo, New York, United States, 14203

Contacts

Lucy Holmes, MD, MPH

716-323-0034LHolmes@upa.chob.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Asthma
  • Children
  • School-based health center
  • NIH Guideline-based care
  • Controller medication
  • Directly Observed Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-06-25.