122 Chapter 5 5 registered in a participating practice (i.e., part of the patients recruited via route B and all patients recruited via route C) can use the app without participation of the HCP. Control group (passive electronic monitoring) Patients in the control group attach the same EMD (Turbu+) to their inhaler (Symbicort Turbuhaler) as the intervention group. However, the EMD is connected to a different smartphone application (Hailie Lite). Actuation data are not visible to patients in this app; the app only shows when the EMD last synchronised data with the smartphone (i.e., ‘Last synced: (date), (time)’). Inhalation data uploaded to the smartphone application will automatically be uploaded to an online portal (Hailie web portal) which is only accessible to the research team. As inhaler actuations are objectively monitored, without patients and HCPs being able to view their inhaler data, this is called ‘passive electronic monitoring’. EMD for reliever inhalers A subgroup of patients, regardless of study arm, are provided with an EMD which is compatible with their reliever inhaler (Hailie sensor, medical device class I, manufactured by Adherium (NZ), CE marked). Compatible relievers are Bricanyl Turbuhaler (containing terbutaline) or Ventolin aerosol (containing salbutamol). As in the control group, the EMD will be attached to the patient’s inhaler and passively monitor inhaler actuation data using the Hailie Lite smartphone application. Again, actuation data uploaded to the online Hailie portal will only be accessible to the research team. Data collection and follow-up Practices Baseline data from the participating practices are collected at the time of enrolment using a standard data collection form. Data include information on practice size, number of patients and number of staff. Patients Considering the pragmatic nature of the study, data are collected during study visits at baseline, and at 6 and 12 months after randomisation. At 3 and 9 months, data are collected via questionnaires sent to the patients. Initially, the study visits took place at the patient’s home. Due to the COVID-19 pandemic we decided to change to remote study visits using video consulting software, to be able to continue the study and avert the risk of COVID-19 infection. As remote study visits allow a large flexibility and are perceived as useful by patients (i.e., remote study visits could be easily combined with work), the remote study set up is continued after social distancing measurements are lifted. In case of technical difficulties (e.g., synchronisation problems) which cannot be solved remotely, or when it is impossible for the patient to videocall, the visit proceeds via a home visit (only when COVID-19 measurements allow for home visits).
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