131 ACCEPTANCE protocol 5 Monitoring and quality assurance The study will be monitored on annual basis according to a monitor plan, by a monitor of the Leiden University Medical Centre who works in a department from the research staff. A structured risk analysis is performed, whereby the risk of this study is considered negligible. Based on this risk, a data monitoring committee is not deemed necessary. Trial status The trial is in the recruitment phase at the time of manuscript submission. The first patient was enrolled on 16 December 2019. End of data collection is expected in March 2023. Dissemination Results of the trial will be submitted to peer-reviewed journals and presented at both national and international conferences, where possible. In addition, we plan to disseminate during public events for patients with asthma and caregivers. Public and patient involvement We set up a patient advisory panel consisting of four trained patient representatives with diverse backgrounds and experience as representatives. The patient advisory panel gives advice during several stages of the research. We received input from the advisory panel on study design, study materials, patient information, recruitment plans and burden to the patient. Alle study materials involving patients such as the smart inhaler programme and videoconference systems, were checked and tested by the panel members. Regular meetings are held with the advisory panel to inform, seek advice, and evaluate the collaboration. No patients were involved in setting the research question or the outcome measures. We plan to disseminate the results of the research to all study participants and to interested audience during public events for people with asthma. Discussion This study protocol details the evaluation of the effectiveness and cost-effectiveness of a smart asthma inhaler programme in primary care in the Netherlands. With a follow-up of 12 months, it is the first study to provide evidence on and insight in the effectiveness of a smart inhaler programme on the long term. To our knowledge, this is also the first RCT that longitudinally assesses the use of a smart inhaler programme in a real-world setting. It becomes increasingly acknowledged that eHealth and health innovations should be investigated in a real-world setting, meaning that the study resembles real practice as much as possible. In this trial, that means that study inclusion is inclusive and patients and participating HCPs do not receive instructions on how often to use the smart inhaler programme, allowing patients and HCPs to interact with the programme in a way it suits their needs. The outcomes of this large multi-centre trial will add to the evidence on the effectiveness of EMDs in the
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