132 Chapter 5 5 treatment of asthma. Because of the pragmatic trial design, it will give important insights in the practical use and acceptability of a smart inhaler programme in clinical practice from the perspective of patients and HCPs. The study will also contribute to the existing knowledge regarding the role of patient characteristics in medication adherence and the use of eHealth based self-management interventions. In the early months of the COVID-19 pandemic, study inclusion was paused for six months. In order to proceed with study activities and continue study inclusion, the study continued as remote research. Remote research methods, including video conference systems and postal delivery of questionnaires and devices are innovative ways of performing research. As such, this study provides insight in how remote studies can be performed in an efficient way and how they may benefit participants and the research as a whole (e.g., remote visits allow more flexibility and can easily fit into the participant’s daily schedules), thereby adding to limited evidence on remote or decentralised trials (61). This study has some methodological challenges. First, due to the nature of the intervention, blinding of patients and participating practices is not possible, introducing the possibility of performance bias (i.e., improved adherence behaviour due to knowledge on allocation). This challenge is often encountered in adherence trials. Changes in behaviour are mostly seen at study start and around study visits and result in increased medication adherence in both intervention and control groups. EMD data from the SYGMA two study showed an average improvement in adherence 1 - 2 weeks before and after a study visit, which normalised after a visit (62). Consequently, frequent study visits may increase medication adherence, which can subsequently improve asthma control over a longer period of time (i.e., more than 6 months). In order to reduce the impact of bias and improve internal validity, the study has a follow-up of 12 months and has a minimal number of research visits (i.e., every 6 months), resembling the check-up frequency of patients with suboptimal asthma in the Netherlands). In addition, medication adherence data around visits will be excluded from the analysis to minimise the potential impact of performance bias. Second, different modes of recruitment and study participation may have an influence on intervention compliance and delivery of the intervention (i.e., delivered to one patient and delivered to all patients of the practice). However, having multiple recruitment strategies increases the reach and enhances the recruitment rate, which is necessary to reach the required study power. Sensitivity analysis will be performed where possible to identify any effects of recruitment ways on outcomes. Finally, it is uncertain what proportion of patients will fulfil all inclusion criteria, especially the inclusion criteria ‘having uncontrolled asthma’ and ‘being nonadherent’. In general, people with limited health literacy and/or a lower socioeconomic position are known to be less adherent to their medication and at higher risk of having suboptimal controlled asthma (63-65). However, this patient population is also known to be less willing to participate in research, have difficulties understanding study content and be anxious towards research or the research team (66). Hence, while asthma patients with lower socioeconomic positions would probably benefit
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