Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities
- Conditions
- Asthma in ChildrenDirectly Observed Therapy
- Interventions
- Other: APP assessment and management of asthma
- Registration Number
- NCT06539312
- Lead Sponsor
- State University of New York at Buffalo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- uncontrolled asthma
- other chronic lung disease such as cystic fibrosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SBHC group APP assessment and management of asthma -
- Primary Outcome Measures
Name Time Method Asthma exacerbations 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 Outcome Measures
Name Time Method Spirometry - FEV1 to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year Forced Expiratory Volume in 1 second
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. Number of ED visits for asthma symptoms based on medical records
Quality of Life - caregiver to be assessed at baseline and at 7-month follow-up for 1 school year Children's Health Survey for Asthma, American Academy of Pediatrics Higher scores mean a better outcome.
Daytime asthma symptoms to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year Frequency of daytime asthma symptoms based on questionnaire minimum value: 0 days maximum value: 28 days Higher scores mean a worse outcome.
Spirometry - FEV1/FVC ratio to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year FEV1/Forced Vital Capacity ratio
Nighttime asthma symptoms to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year Frequency of nighttime asthma symptoms based on questionnaire minimum value: 0 nights maximum value: 28 nights Higher scores mean a worse outcome.
Hospitalizations from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year. Number of hospitalizations based on medical records
Activity Limitation to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year Degree of activity limitation based on questionnaire Higher scores mean a worse outcome.
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. Number of urgent care visits for asthma symptoms based on medical records
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. Number of missed school days based on school records
Trial Locations
- Locations (1)
University at Buffalo, Department of Pediatrics
🇺🇸Buffalo, New York, United States