Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities
NCT Number: NCT06539312
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma in Children|Directly Observed Therapy
Interventions: OTHER: APP assessment and management of asthma
Sponsor: State University of New York at Buffalo
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: CHILD
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2028-06

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.

Primary Outcome Measures: Asthma exacerbations, Number of asthma exacerbations requiring systemic steroids based on medical records, 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.
Secondary Outcome Measures: Daytime asthma symptoms, Frequency of daytime asthma symptoms based on questionnaire minimum value: 0 days maximum value: 28 days Higher scores mean a worse outcome., to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year|Nighttime asthma symptoms, Frequency of nighttime asthma symptoms based on questionnaire minimum value: 0 nights maximum value: 28 nights Higher scores mean a worse outcome., to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year|Spirometry - FEV1, Forced Expiratory Volume in 1 second, to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year|Spirometry - FEV1/FVC ratio, FEV1/Forced Vital Capacity ratio, to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year|ED visits, Number of ED visits for asthma symptoms based on medical records, 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.|Urgent care visits, Number of urgent care visits for asthma symptoms based on medical records, 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.|Hospitalizations, Number of hospitalizations based on medical records, from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.|Quality of Life - caregiver, Children's Health Survey for Asthma, American Academy of Pediatrics Higher scores mean a better outcome., to be assessed at baseline and at 7-month follow-up for 1 school year|Activity Limitation, Degree of activity limitation based on questionnaire Higher scores mean a worse outcome., to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year|school absenteeism, Number of missed school days based on school records, 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.