Feasibility, effectiveness and safety of self-management in pulmonary rehabilitation 157 Data management All data will be processed anonymously, according to the guidelines of the University of Groningen (RUG). The data will be stored digitally on the highly secured server of the RUG. All local databases are secured with passwordprotected access systems. All records that contain names or other personal identifiers, such as informed consent forms are stored separately and pseudonymized from study records identified by code number [39]. The data may be used for a scientific publication and for educational purposes, but it will never be traceable to the individual patient. Patients can always ask to withdraw data until personal identifiers have been removed. Ethics approval This study protocol is registered with the number METc 2023/074. The METc UMCG has concluded that the study is not clinical research with human subjects as meant in the Medical Research Involving Human Subjects Act (WMO). Discussion This study protocol details the evaluation of the safety and effectiveness of COPDpatient self-management regarding pulmonary rehabilitation according to guideline recommendations in primary physiotherapy practices in the Netherlands. With a follow-up of 12 months, the study will provide insight in the relationship between self-management and adherence, and the COPD-specific health outcomes exercise capacity, disease burden, health related quality of life, MRC dyspnea score, and lung attacks, over the medium term. In addition, this study also evaluates the predictive validity of the Predicting Adherence in paTients with CHronic diseases (PATCH) tool, and the implementation outcomes feasibility and acceptability of self-management and the PATCH tool. It has become increasingly acknowledged that health innovations (including providing healthcare in an alternative manner) should be evaluated in real-life conditions; this study resembles real-life as much as possible. The inclusion is inclusive and patients and the participating physiotherapists do not receive prescribed instructions about where unsupervised exercise should take place, and they are expected to follow the commonly used Dutch KNGF Guideline COPD. This allows patients and physiotherapist to decide on the setting and type of exercise that best suits the patient's needs and context based on shared-decision making. Research design As research design a prospective treatment cohort was chosen, because 1. no intervention will be implemented, the reduction (in this case 50%) of clinical
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