School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial

Abstract

Background: School-supervised use of a once-daily inhaled corticosteroid regimen (supervised therapy) can improve medication adherence and asthma control.

Objective: We sought 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 students receiving immediate intervention and 143 students receiving delayed intervention provided 1 or more ACQ data points, were between 6 and 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 students receiving immediate intervention 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 students receiving immediate and delayed intervention 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 to 0.14).

Discussion: Compared with usual care, supervised therapy did not improve asthma control among this population of Latino students. Additional research is warranted to confirm these results.

Trial registration: ClinicalTrials.gov NCT01997463.

Keywords: Schools; anti-inflammatory agent; asthma; child; cluster randomized trial; directly observed therapy; inhaled corticosteroid; medication adherence; randomized controlled trial.

Conflict of interest statement

Disclosure of potential conflict of interest: The authors of this manuscript have reported no relevant conflicts of interest.

Copyright © 2018 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1.

SAMS Design and Data Collection Timeline

Figure 2.

CONSORT Diagram for the Supervised Asthma in Schools (SAMS) Cluster-Randomized Trial.

Figure 3.

Model Estimated Mean Asthma Control Questionnaire (ACQ) Scores during Year 1 (Intervention Year, Visits 1 – 4) and Year 2 (Delayed Intervention Year, Visits 5 – 8) for Supervised Therapy and Usual Care Students.

Figure 4.

Association between 28-Day Adherence and Asthma Control Questionnaire (ACQ) Score with Least−Squares Means Curve of ACQ Scores Averaged over Time with 95% Confidence Interval. Data from 230 students who provided ≥1 ACQ value and had exactly 28 days of calculable controller usage prior to the ACQ measurement (230 participants, 892 data points). Only data fitting the above criteria and with adherence between 25% and 75% are shown. The modeled relationship between 28-day adherence and ACQ is non-significant (p=0.62).