120 Chapter 5 5 and (8) inability to understand Dutch. Patients with any other condition which, at the general practioner’s and/or investigator’s discretion, is believed to potentially present a safety risk or impact the study results are also excluded from study participation. Randomisation, sequence generation and allocation concealment Primary care practices are block-randomised using a computer-generated permuted block scheme with random block sizes of 4 and 6, stratified by practice size (≤2500 patients or >2500 patients). The randomisation code is recorded in the randomisation database which is accessible only to the coordinating researcher and research assistants. Randomisation at practice level minimises the risk of contamination across intervention and control groups, as patients from the same practice are managed by the same HCPs. Randomisation takes place when the first patient of the general practice has finished the run-in period and will start the smart inhaler programme or enter the control group. Subsequently, practice staff are notified of the allocation of their practice. From this point no additional patients from the same practice can be recruited. This minimises the risk of recruitment bias by practices based on knowledge on allocation. All patient participants that are registered to a participating practice receive the intervention or control depending on the allocation of the practice. Each individual patient participant that is not registered in a participating practice (i.e., part of the patients recruited via route B and all patients recruited via route C) is considered a separate cluster. The cluster will be randomised using the same randomisation scheme and procedures. Randomisation takes place after 6 weeks run-in period when patients fulfil all inclusion criteria. Study groups All patients receive usual care according to the Dutch National primary care asthma Guidelines (32). Intervention (smart inhaler programme) Patients randomised to the smart inhaler programme will use an EMD, Turbu+ Device (medical devices class I, manufactured by Adherium (NZ), CE marked), which is a small battery-powered electronic data logger. The EMD has previously been used in a research context in the Netherlands (25). The EMD is attached to the patient’s inhaler (Symbicort Turbuhaler). The device automatically logs inhaler actuation data including an event stamp and time-and-date stamp. A validation study on the detection of inhaler events as recorded by the Turbu+ device found an accuracy of 99.9% by bench testing over a 12-week period (33). Logged actuation data are sent to an application on a smartphone (Turbu+ Insights). To enable upload of stored actuation data, the app needs to be installed on a smartphone and the device must be paired with the phone using a Bluetooth connection (instructions provided in the app). The upload of new data from the device to the app occurs automatically if the device is within range (<5 meters) of the phone. When the phone is out of range, data will be stored on the device and uploaded to the app when the phone is within range. It is also possible to manually upload data to the app. The battery light-emitting
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