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

NCT ID: NCT06539312

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma in Children Directly Observed Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SBHC group

Group Type EXPERIMENTAL

APP assessment and management of asthma

Intervention Type OTHER

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.

PCP group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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DOT of morning dose of controller medication

Eligibility Criteria

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Inclusion Criteria

* uncontrolled asthma

Exclusion Criteria

* other chronic lung disease such as cystic fibrosis
Minimum Eligible Age

4 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Lucy Holmes, MD

Clinical Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University at Buffalo, Department of Pediatrics

Buffalo, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lucy CY Holmes, MD, MPH

Role: CONTACT

716-323-0034

Deanna Hamilton, MSEd

Role: CONTACT

716-323-0060

Facility Contacts

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Lucy Holmes, MD, MPH

Role: primary

716-323-0034

Other Identifiers

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R01MD018384

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007712

Identifier Type: -

Identifier Source: org_study_id

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