directly observed therapy, randomized controlled trial, inhaled corticosteroid, cluster randomized trial. Supervised Asthma Medicine in Schools 4 Abbreviations: ACQ Asthma Control Questionnaire ALA American Lung Association ED emergency department FPL federal poverty level ICC intraclass correlation coefficient ICS inhaled corticosteroid MAR medication administration record MID minimally important difference NSLP National School Lunch Program OAS Open Airways for Schools OCS oral corticosteroid SAMS Supervised Asthma Medicine in Schools study TUSD Tucson Unified School District 95% CI 95% confidence interval Supervised Asthma Medicine in Schools 5 Word count (abstract; 250/250) Word count (manuscript; 4054/3500) Tables (3) Figures (4) Supplemental Tables (3) Supplemental Figures (2) Clinical Implications (30/30 words): School-supervised use of a once-daily inhaled corticosteroid regimen achieved 53% calendar adherence; however, it did not improve asthma control, school absences, or health care use as compared to usual care. Capsule Summary (35/35 words): Prior studies have demonstrated that school-supervised use of a once-daily inhaled corticosteroid regimen can improve adherence and asthma control;however, these results were not replicated in this comparative effectiveness trial conducted primarily among Latino children.Supervised Asthma Medicine in Schools 6 BACKGROUND: School-supervised use of a once-daily inhaled corticosteroid regimen (supervised therapy) can improve medication adherence and asthma control.OBJECTIVE: To evaluate the effectiveness of supervised therapy in a unique setting and population.
METHODS:We conducted a cluster-randomized trial of supervised therapy in 20 elementary schools with a disproportionate enrollment of low income Latino students. Schools were purposively selected, matched, and randomized to receive 9-months of supervised therapy with mometasone furoate or usual care. All English-or Spanish-speaking students with self-reported asthma were eligible. The Asthma Control Questionnaire (ACQ) was interviewer-administered quarterly at school. Students in supervised therapy schools were hypothesized to have lower ACQ scores than students in usual care schools.RESULTS: Of 393 enrolled students, 189 immediate intervention and 143 delayed intervention students provided ≥1 ACQ data point, were between 6 -10 years of age, and were included in the primary analysis. At baseline, 39% of students reported taking a controller medication and 24% had well-controlled asthma. Eighty percent of immediate intervention students were prescribed mometasone. Schools administered 98% of prescribed doses when students attended school. Absences, weekends, and holidays reduced calendar adherence to 53%.During the first year, the mean ACQ score for immediate and delayed intervention students was 1.55 (95% CI 1.41, 1.70) and 1.64 (95% CI 1.47, 1.80), respectively. The estimated treatment effect was -0.08 (95% CI -0.31, 0.14).