Novel electronic adherence monitoring devices in children with asthma: a mixed-methods study

Abstract

Introduction: Adherence monitoring to inhaled corticosteroids is an essential component of asthma management. Electronic monitoring devices (EMD) provide objective data on date, time and number of actuations. However, most give no information on inhalation. Novel EMD (NEMD) platforms have the potential to monitor both activation and inhalation.

Aim: To assess the feasibility of NEMDs, in terms of usability, acceptability to patients and healthcare professionals and accuracy.

Methods: This was an open-label, prospective, mixed-methods, pragmatic randomised study. Children with asthma attending specialist tertiary care were randomised to one of four NEMD: Remote Directly Observed Therapy (R-DOT), Hailie Smartinhaler, INhaler Compliance Assessment device (INCA) and the Rafi-tone App. Following monitoring, participants were invited to focus groups or one-to-one interviews. Usability and acceptability were evaluated using themes identified from the focus groups and interviews. Adherence accuracy was determined using adherence data from each NEMD.

Results: Thirty-five children were recruited; 18 (51%), (11 males, median age 13.5 (7-16) years) completed monitoring, 14 (78%) provided feedback. Participants identified various features such as ease of use and minimal effort as desirable criteria for an NEMD. The Hailie and INCA fulfilled these criteria and were able to record both actuation and inhalation. Negative themes included a 'Big Brother' effect and costs.

Conclusion: There was no 'one size fits all', as participants identified advantages and disadvantages for each NEMD. Devices that can easily calculate adherence to activation and inhalation have the potential to have greatest utility in clinical practice. Each NEMD has different functionality and therefore choice of platform should be determined by the needs of the patient and healthcare professional.

Keywords: asthma; inhaler devices; paediatric asthma.

Figure 1

Novel Electronic Monitoring Devices used in the studyINCA, inhaler compliance assessment; R-DOT, remote directly observed therapy.

Figure 2

CONSORT flow diagram for NEMD study. ADHD, attention-deficit hyperactivity disorder; ASD, autistic spectrum disorder; Safeguarding concern: child in need plans were in place or about to be placed. CONSORT, Consolidated Standards of Reporting Trials; DOT, directly observed therapy; INCA, inhaler compliance assessment; NEMD, novel electronic monitoring device; R-DOT, remote DOT.