116 Chapter 5 5 evaluating how these factors interact in affecting medication adherence and clinical outcomes, we will be able to identify which patients would benefit most from the use of a smart inhaler based self-management programme. To our knowledge, this is the first pragmatic randomised trial to evaluate the long-term effects of a smart inhaler based asthma self-management programme on medication adherence and clinical outcomes, to collect data on patient characteristics and acceptance, and to perform a cost-effective analysis. Aims The primary objective of our study is to evaluate the effectiveness of a smart inhaler programme on medication adherence in adults with uncontrolled asthma compared with control (i.e., passive monitoring with an EMD) over 12 months. Secondary objectives are to evaluate clinical outcomes (i.e., asthma control, reliever use, exacerbations, and asthma-related quality of life), to evaluate which patient groups would benefit most based on baseline patient characteristics (i.e., self-efficacy and attitude, beliefs about medicine, illness perception, eHealth literacy); to evaluate usability and acceptability of the programme by patients and HCPs, and to evaluate the cost-effectiveness of a smart inhaler programme. The purpose of this paper is to describe the rationale and design of the trial. Methods Study design This is a pragmatic, multi-centre, open-label cluster randomised controlled trial (RCT) of 12 months in primary care in the Netherlands. Primary care practices are eligible if they have access to a computer and internet. Eligible primary care practices that provided consent are randomised to either intervention (smart inhaler programme) or control (usual care + passive electronic monitoring). Participating patients receive either intervention or control depending on the allocation of the cluster. Each patient is screened for eligibility and has follow-up measurements at 3, 6, 9 and 12 months from baseline. The baseline is preceded by a 6-week runin period to assess whether patients are non-adherent. The study is run by three centres in the Netherlands (Leiden University Medical Centre, General Practitioners Research Institute and University Medical Centre Groningen). Practices and patients are recruited throughout the Netherlands. Since inclusion is ongoing during the COVID-19 pandemic, a number of amendments were made to continue inclusion, warrant the safety of the patients and the research team and increase recruitment pace. All protocol amendments with reason are enlisted in Supplementary Table E1. The design of the study and flow of practices and patients is depicted in Figure 1. The protocol is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (31). The SPIRIT checklist is provided in Supplementary Table E2.
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