Clinical trial NCT06539312: Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities
Official title: Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Directly Observed Therapy
Keywords: Asthma
Children
School-based health center
NIH Guideline-based care
Controller medication
Directly Observed Therapy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-08-06
Enrollment: 400
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* uncontrolled asthma

Exclusion Criteria:

* other chronic lung disease such as cystic fibrosis

Primary outcomes:
measure: Asthma exacerbations
timeFrame: 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 outcomes:
measure: Daytime asthma symptoms
timeFrame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
measure: Nighttime asthma symptoms
timeFrame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
measure: Spirometry - FEV1
timeFrame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
measure: Spirometry - FEV1/FVC ratio
timeFrame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
measure: ED visits
timeFrame: 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.
measure: Urgent care visits
timeFrame: 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.
measure: Hospitalizations
timeFrame: from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.
measure: Quality of Life - caregiver
timeFrame: to be assessed at baseline and at 7-month follow-up for 1 school year
measure: Activity Limitation
timeFrame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
measure: school absenteeism
timeFrame: 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.
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Department of Pediatrics
state: New York
Study officials:
References: