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 — OTHERAPPs 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
- Lucy CY Holmes, MD, MPH716-323-0034
- Deanna Hamilton, MSEd716-323-0060
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University at Buffalo, Department of Pediatrics | Buffalo | New York | 14203 |
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