The study is a single-blinded randomized-controlled pilot trial with a goal of 30 participants ages 10-17 years diagnosed with IDD and moderate-to-severe asthma. Subjects are recruited from subspecialty clinics and a primary care FQHC at a large, urban academic children's hospital. Participants in the intervention group are assigned to use smart inhalers daily for 8 weeks, and the control group receives standard asthma education.
All participants attend three visits over 8 weeks, each scheduled four weeks apart. Primary outcomes, feasibility and acceptability, are assessed by data completeness and satisfaction surveys. Secondary outcomes, the Inhaler Proficiency Scales, are measured by the smart inhaler and by a trained observer and analyzed by Spearman's correlation test. Tertiary outcomes, Forced Expiratory Volume (FEV1) in one second, and Peak Expiratory Flow (PEF), are measured by a spirometer. Demographics and outcomes are reported as frequencies (%), mean (SD), or median (IQR). Analyses will utilize generalized linear mixed-effects models to account for the within-participant correlation.
