Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma in Children
- Sponsor
- State University of New York at Buffalo
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Asthma exacerbations
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Lucy Holmes, MD
Clinical Associate Professor of Pediatrics
State University of New York at Buffalo
Eligibility Criteria
Inclusion Criteria
- •uncontrolled asthma
Exclusion Criteria
- •other chronic lung disease such as cystic fibrosis
Outcomes
Primary Outcomes
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.
Number of asthma exacerbations requiring systemic steroids based on medical records
Secondary Outcomes
- Spirometry - FEV1(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.)
- Quality of Life - caregiver(to be assessed at baseline and at 7-month follow-up for 1 school year)
- Daytime asthma symptoms(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)
- Nighttime asthma symptoms(to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year)
- Hospitalizations(from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.)
- Activity Limitation(to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year)
- Urgent care 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.)
- school absenteeism(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.)