Can electronic monitoring with a digital smart spacer support personalised medication adherence and inhaler technique education in patients with asthma?: Protocol of the randomised controlled OUTERSPACE trial

Abstract

IntroductionMedication adherence and inhaler technique in patients with asthma remain suboptimal. A digital, smart spacer may support personalised adherence and inhaler technique education. The aim of this study is to assess the feasibility of undertaking a definitive randomised controlled trial of personalised, smart spacer data-driven education and explore clinical benefits.Methods and analysisWe present the design of the multicentre, randomised controlled OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE feasibility trial of 2 months. Patients will be recruited from four Dutch general practices. At t=−1, patients with asthma ≥18 years using inhaled corticosteroids±long-acting beta-agonists±short-acting beta-agonists administered with a pressurised-metered-dose-inhaler and spacer (n=40) will use a smart spacer for 1 month. The rechargeable CE-marked smart spacer (Aerochamber Plus with Flow Vu) includes a sensor that monitors adherence and inhalation technique to prescribed dosing regimen of both maintenance and reliever inhalers. After 1 month (t=0), patients are 1:1 randomised into two groups: control group (usual care) versus intervention group (personalised education). At t=-1, t=0 and t=1 month, the Asthma Control Questionnaire (ACQ), Work Productivity and Activity Impairment (WPAI) questionnaire and Test of Adherence to Inhalers (TAI) are administered and fractional exhaled nitric oxide (FeNO) is assessed. At t=0 and t=1, spirometry is performed. At t=1, usability and satisfaction will be analysed using the System Usability Scale and interviews with patients and healthcare providers. Primary outcome is the overall feasibility of a definitive trial assessed by patient recruitment speed, participation and drop-out rate. Secondary outcomes are patient and healthcare provider satisfaction and exploratory clinical outcomes are adherence, inhaler technique, TAI score, FeNO, lung function, ACQ and WPAI.Ethics and disseminationEthical approval was obtained from the RTPO in Leeuwarden, Netherlands (number: NL78361.099.21). Patients will provide written informed consent. Study findings will be disseminated through conferences and peer-reviewed scientific and professional journals.Trial registration numberNL9637.

Electronic Monitoring Devices to Support Inhalation Technique in Patients with Asthma: a Narrative Review

“…A timestamp is recorded for each controller and reliever actuation. Data is stored on an SD card for transfer to a personal computer [39,40]. The device is rechargeable and must be charged every 4 to 6 weeks.…”

“…The primary outcome is the overall feasibility of a definitive trial assessed by patient recruitment speed, participation and drop-out rate. Secondary outcomes are patient and HCP satisfaction, and exploratory clinical outcomes are adherence, inhaler technique, Test of Adherence to Inhalers score, fractional exhaled nitric oxide, lung function, Asthma Control Questionnaire and Work Productivity and Activity Impairment questionnaire [40].…”

Half a Century of Fragmented Research on Deviations from Advised Therapies: Is This a Good Time to Call for Multidisciplinary Medication Adherence Research Centres of Excellence?

“…Several media, including newspapers, radio and television channels, had news items on the launch of MAECON. Over the years that followed, MAECON has implemented several research projects related to medication adherence, including clinical trials with innovative digital technologies, such as digital inhalers, electronic spacers [ 20 ], smart pill bottles and blisters [ 21 ], as well as novel bioanalytical essays for measuring adherence in body fluids [ 22 ] and practical adherence-enhancing tools have been studied and developed [ 23 ]. Additionally, several systematic reviews on effective interventions were performed [ 24 ].…”

Digital spacer data driven COPD inhaler adherence education: The OUTERSPACE proof-of-concept study

“…the Aerochamber, was developed (Fig. 1) [8]. In short, it is a rechargeable device that measures exact moment of intake of both reliever and controller, as well as inhaler errors including: multiple actuations, no inhalation, delayed inhalation, excessively high flow and low inhaled volume.…”

“…In short, it is a rechargeable device that measures exact moment of intake of both reliever and controller, as well as inhaler errors including: multiple actuations, no inhalation, delayed inhalation, excessively high flow and low inhaled volume. The internal resistance of the digital Aerochamber is not different from the original Aerochamber [8]. Data are stored on an SD-card that can be read out and visualized.…”