Sensor-Based Electronic Monitoring for Asthma: A Randomized Controlled Trial

Abstract

BACKGROUND: Although sensor-based monitoring of daily inhaled corticosteroids (ICSs) and short-acting β-agonist medications may improve asthma outcomes, the effectiveness of these interventions in diverse pediatric populations remains unclear. METHODS: Caregiver and child dyads were randomly assigned to receive inhaler sensors that allowed for caregiver and clinician electronic monitoring of medications. End points included Asthma Control Test scores (>19 indicated asthma control) and asthma health care use. Caregiver quality of life (QoL) and child ICS adherence were also assessed. Multilevel models were used to estimate adjusted changes from baseline. RESULTS: Dyads were assigned to the control (n = 127) or intervention (n = 125) arms. At the end line, the mean Asthma Control Test score increased from 19.1 (SE = 0.3) to 21.8 (SE = 0.4) among the intervention and from 19.4 (SE = 0.3) to 19.9 (SE = 0.4) among the control (Δintervention-control = 2.2; SE = 0.6; P < .01). Adjusted rates of emergency department visits and hospitalizations among the intervention were significantly greater (incidence rate ratioemergency department = 2.2; SE = 0.5; P < .01; incidence rate ratiohospital = 3.4; SE = 1.4; P < .01) at endline than the control. Caregiver QoL was greater among the intervention at the endline (Δintervention-control = 0.3; SE = 0.2; P = .1) than the control. CONCLUSIONS: Findings suggest that sensor-based inhaler monitoring with clinical feedback may improve asthma control and caregiver QoL within diverse populations. Higher health care use was observed among the intervention participants relative to the control, indicating further refinement is warranted.