Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study

Abstract

Background Many asthmatic children suffer from uncontrolled asthma with frequent exacerbations, despite an optimal treatment plan using inhalation medication. Studies have shown that therapy adherence and inhalation technique are often suboptimal in asthmatic children, but these have traditionally been hard to measure. A novel device functioning as an add-on to the inhaler has been developed to measure both aspects by recording vibration patterns during inhalation. This data can be converted to smart feedback and provided to patients immediately via a mobile application. The aim of this study is to improve asthma control in children between 6 and 18 years old by providing immediate smart feedback on the intake of inhalation medication. Asthma control will be measured by forced expiratory volume in 1 s, (Childhood) Asthma Control Test ((c-)ACT) score, and lung function variability and reversibility. Methods The study will be performed in Medisch Spectrum Twente (Enschede, The Netherlands). The goal is to include 68 uncontrolled moderate to severe asthmatic children between 6 and 18 years old who receive controller inhalation medication through the Nexthaler®, Ellipta®, or Spiromax®. The study consists of three phases. Phase 1 is observational and will last 4 weeks to observe the baseline adherence and inhalation technique as monitored by the add-on device. A randomised controlled trial lasting 6 weeks will be performed in phase 2. Patients in the intervention group will receive immediate smart feedback about the performed inhalations via a mobile application. In the control group, adherence and inhalation technique will be monitored, but patients will not receive feedback. In phase 3, also lasting 6 weeks, the feedback will be ceased for all children and revision of current therapy may occur, depending on the findings in phase 2. Asthma control can be assessed by means of spirometry (both at home and in the hospital) and (c-)ACT questionnaires. Discussion Immediate smart feedback may improve therapy adherence and inhalation technique, and thus asthma control in children and prevent unnecessary switches to targeted biologics. Performing this study in children is desired, since they are known to react differently to feedback and medication than adults. Trial registration Dutch Trial Register NL7705. Registered on 29 April 2019

Assessing adherence to inhaled therapies in asthma and the emergence of electronic monitoring devices

“…The provider portal displays a dashboard of patient data, notifications about patients at risk of an exacerbation and monthly reports on patient progress, allowing the monitoring of large patient populations. A study evaluating its use is currently underway in children with uncontrolled asthma (Dutch Trial Register NL7705) [58].…”

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

“…In a study by Sloots et al in patients with COPD and concurrent heart failure, adherence to inhaled medication was 98.4%, but 51.9% of inhalations were performed improperly, with 'inhaling too shortly' (1.25 s) being the most common error (79.6%) [35]. A study is underway in children with uncontrolled asthma intending to improve asthma control by providing immediate feedback, including on inhalation technique (Dutch Trial Register NL7705) [36].…”

Advancing Digital Solutions to Overcome Longstanding Barriers in Asthma and COPD Management

“…These include the Maximizing Adherence and Gaining New Information for Your COPD (MAGNIFY) primary care cluster randomized trial in COPD, designed to investigate whether adherence support can improve COPD outcomes in real life in the UK ( https://opri.sg/magnify/ ). 83 In children with asthma, ongoing studies include the Improving Adherence by Guiding Inhalation via Electronic Monitoring (IMAGINE) I trial using the Respiro ® add-on sensor, 84 and a pilot study of the HeroTracker electronic monitoring device linked to BreatheSmart mobile app. 85 In adults and adolescents with asthma, the CONNECT study program (NCT03890666 and NCT04677959) is exploring the effects of the albuterol and (in CONNECT2) the fluticasone/salmeterol Digihaler on asthma control.…”