Smart Inhaler Randomized Controlled Trial for Improving Inhaler Technique in Adolescents With Intellectual and Developmental Disabilities and Asthma.

OBJECTIVE

To evaluate the feasibility, acceptability, and usability of a real-time feedback smart inhaler for adolescents with intellectual and developmental disabilities (IDD) and asthma; assess preliminary efficacy in improving metered-dose inhaler (MDI) technique; and explore device-measured proficiency and lung function in the full cohort, alongside a predefined autism subgroup analysis.

METHODS

We conducted a single-center, single-blind, pilot randomized controlled trial involving 28 adolescents (aged 10-17 years) with IDD and asthma. Participants were randomized 1:1 to an intervention group using smart inhalers with audiovisual feedback for 8 weeks, or a control group receiving standard asthma education. Primary outcomes were parent- and adolescent-reported feasibility, acceptability, and usability. The secondary outcome was observer-rated inhaler proficiency. Exploratory outcomes were full-cohort device-measured inhaler proficiency and lung function (FEV1 and PEF), alongside a predefined autism subgroup analysis.

RESULTS

The intervention was feasible, acceptable, and usable, yielding high parent and adolescent motivation and satisfaction. The intervention group demonstrated significantly greater improvement in observer-rated Inhaler Proficiency Scale scores from baseline to week 8 compared to the control group (mean difference 1.5 points; 95% CI: 0.4-2.6; P = .02). Exploratory outcomes showed no significant between-group differences in lung function or device-measured proficiency. However, the autism subgroup exhibited inhaler technique improvements consistent with the broader cohort.

CONCLUSIONS

Smart inhalers are feasible, acceptable, and usable for adolescents with IDD, and are associated with significant improvement in observer-rated inhaler technique when combined with standard clinical education. Given the inherent challenges of spirometry in this population, future studies should incorporate effort-independent clinical assessment measures.