123 ACCEPTANCE protocol 5 T-1 (first visit) and run-in period During the first visit, electronic or handwritten informed consent will be provided. Electronic signature was initiated during the COVID-19 pandemic and proceeds via DocuSign, and electronic signature software that meets all legal requirements for eSignatures according to the European Union (EU) law ‘electronic Identification, Authentication and trust services’. After signing the informed consent, initial eligibility is confirmed according to the inclusion and exclusion criteria. Subsequently, demographics (date of birth, sex, education level, smoking history and pack years), medical history (age of asthma onset, number of exacerbations, asthma-related hospital admissions and emergency department visits in the prior year, and other comorbidities) and self-reported asthma medication use will be collected. Patients are provided the EMD (Turbu+ device), instal the app (Hailie Lite) on their smartphone following instructions from the researcher and then enter the 6-week run-in period in which inhaler actuations are objectively monitored. T0 (baseline visit) After the run-in period, final eligibility will be confirmed based on the actuation data collected with the EMD during the run-in period. Patients who are classified as nonadherent (see ‘the Inclusion and exclusion criteria’ for definition) will continue study participation. Before giving informed consent, patients are informed that an additional selection takes place after the run-in period, but they are not informed about what the additional selection entails (i.e., selection based on the level of medication adherence). Awareness of patients hereof probably affects the adherence behaviour of patients and could lead to biased results, especially because the primary outcome measures of this study is medication adherence. During the baseline visit, baseline data are collected through questionnaires and structured interviews (see Table 1). Furthermore, patients are informed of their assigned randomised condition (i.e., intervention or control). The EMD of patients in the intervention group is replaced, to ensure data collected in the run-in period are not visible in the intervention app, and instructions on how to download and use the intervention app are provided. Follow-up visits (T6 and T12) At visits T6 and T12, data are collected through structured interviews and questionnaires (see Table 1), as this helps to keep patients involved, retain participation and reduce the amount of missing data. All patients receive a new EMD prior to visit T6 to ensure sufficient battery throughout the study.
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