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

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT06539312
Status
Recruiting

Conditions

  • Asthma in Children
  • Directly Observed Therapy

Eligibility Criteria

Sex
ALL
Age
4 Years - 13 Years
Healthy Volunteers
Not accepted

Interventions

  • APP assessment and management of asthma — 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.

Study Details

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.

Key Dates

Start date
Sep 27, 2024
Status verified
Apr 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: SBHC group
  • No Intervention: PCP group

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

Locations (1)

FacilityCityStateZIPSite coordinators
University at Buffalo, Department of PediatricsBuffaloNew York14203
Lucy Holmes, MD, MPH
716-323-0034

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