Charlotte Poot

115 ACCEPTANCE protocol 5 Background and rationale Asthma is characterised by chronic inflammation of the airways and affects more than 300 million adults and children worldwide (1). Despite the availability of effective treatment, nearly half of all asthma patients remain inadequately controlled (2). Suboptimal control is associated with increased symptom burden, increased risk of exacerbations and reduced quality of life, and may lead to short-acting β-2 agonist (SABA) overreliance (3-7). Furthermore, an increased economic burden in terms of direct costs (healthcare utilisation and medication) and indirect costs (loss of productivity and absenteeism) is associated with poor control (8,9). Poor medication adherence and incorrect inhaler use could lead to suboptimal asthma control (10-13). Globally, medication adherence ranges from 13% to 52% (14,15). Numerous factors contribute to poor medication adherence, including illness perceptions, medication beliefs (e.g. concerns about side effects), forgetfulness, difficulty understanding specifics of the regimen (i.e. inhaler technique), attitude towards the illness (i.e. the patient’s willingness to work with physicians to manage the disease) and self-efficacy (i.e. the patient’s confidence in his or her ability to contribute to the management of the disease) (16,17). As such, medication adherence interventions ask for a comprehensive and personalised approach; one that is tailored towards reasons of non-adherence (18). Having objective data on medication adherence is essential to inform interventions. Electronic monitoring devices (EMDs) can provide real-time data on medication adherence to both patients and healthcare professionals (HCPs). Insight in adherence data can support clinical decision making, for example, by being able to identify suboptimal adherence as reason for poor treatment response (19). By combining the EMD with an application on the patient’s smartphone there is increasing potential for use in self-management of asthma (20,21). These so called “smart inhalers” are able to upload real-time data to the patient’s smartphone. As such, patients can receive tailored audio-visual medication reminders and motivational messages, and gain insight in inhaler use. The use of an app makes it possible to integrate multiple self-management components such as the possibility to track symptoms and triggers over time. In addition, it is possible to provide tailored self-management care that can be delivered outside of office hours and scheduled appointments on a more timely manner. Various studies have found that smart inhalers increase medication adherence (19, 22-26), but an improvement in asthma control is only shown in children (27). However, those studies only evaluated the short-term effects (≤ 6 months) of smart inhalers. Also, evidence on the cost-effectiveness of smart inhaler based selfmanagement programmes is lacking. Furthermore, acceptance and eHealth usage have not been evaluated in prior studies on smart inhalers, whereas it is known that the effectiveness of an asthma smart inhaler based self-management programme may be compromised by adoption failure and poor adherence to the intervention (28). Acceptance and eHealth usage depend on multiple patient characteristics, including illness perception, beliefs about medication and eHealth literacy (29,30). By

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