NCT06539312

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Sep 2024Apr 2028

First Submitted

Initial submission to the registry

July 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

January 22, 2026

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

July 31, 2024

Last Update Submit

January 20, 2026

Conditions

Asthma in ChildrenDirectly Observed Therapy

Keywords

AsthmaChildrenSchool-based health centerNIH Guideline-based careController medicationDirectly Observed Therapy

Outcome Measures

Primary Outcomes (1)

  • Asthma exacerbations

    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 Outcomes (10)

  • Daytime asthma symptoms

    to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

  • Nighttime asthma symptoms

    to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

  • Spirometry - FEV1

    to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

  • Spirometry - FEV1/FVC ratio

    to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

  • ED visits

    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.

  • +5 more secondary outcomes

Study Arms (2)

SBHC group

EXPERIMENTAL
Other: APP assessment and management of asthma

PCP group

NO INTERVENTION

Interventions

APP assessment and management of asthmaOTHER

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.

Also known as: DOT of morning dose of controller medication
SBHC group

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • uncontrolled asthma

You may not qualify if:

  • other chronic lung disease such as cystic fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo, Department of Pediatrics

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Directly Observed TherapyAsthma

Condition Hierarchy (Ancestors)

Medication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Lucy CY Holmes, MD, MPH

CONTACT

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

Deanna Hamilton, MSEd

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Pediatrics

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 6, 2024

Study Start

September 27, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

January 22, 2026

Record last verified: 2025-04

Locations

US(1)