Design of the supervised asthma therapy study: implementing an adherence intervention in urban elementary schools

Area of Science:

• Pediatric Pulmonology
• Public Health Interventions
• Clinical Trial Design

Background:

• Inhaled corticosteroids (ICS) are effective for asthma control but adherence is low in children, particularly in urban, low-income populations.
• Low adherence to ICS correlates with higher asthma-related morbidity in vulnerable pediatric populations.
• Addressing adherence barriers is crucial for improving asthma management outcomes in children.

Purpose of the Study:

• To design and implement a school-based clinical trial evaluating an intervention to enhance ICS adherence in a predominantly minority pediatric population.
• To assess the feasibility of school-based asthma management programs.
• To examine the impact of supervised therapy on asthma exacerbations.

Main Methods:

• A two-group randomized longitudinal trial comparing school-based supervised asthma therapy to parent-supervised therapy over 15 months.
• Enrollment of 290 students from urban elementary schools, with data collected via a web-based system.
• Primary outcome: time-averaged difference in monthly asthma exacerbations between groups.

Main Results:

• The study successfully recruited and randomized 290 students (average age 10.0 years, 91% African American).
• A web-based data collection system facilitated school-based data capture.
• Study completion and data analysis are pending.

Conclusions:

• Daily medication supervision and data collection interventions are feasible within the elementary school setting.
• School-based interventions show promise for improving adherence and potentially reducing morbidity in pediatric asthma.
• The study design supports the successful implementation of similar health interventions in schools.