Feasibility, effectiveness and safety of self-management in pulmonary rehabilitation 145 physiotherapy practice in the Netherlands. The secondary aim is to evaluate the predictive validity of the PATCH tool in this same cohort of patients over 12 months. Finally, a third aim is to evaluate perceived feasibility and acceptability of selfmanagement and the PATCH tool by patients and physiotherapists. The purpose of this paper is to describe the rationale and design of the study. Methods/design Study design and setting This is a protocol of a hybrid type 1 effectiveness-implementation design that combines an effectiveness study with an implementation study [19]. A prospective cohort study of 12 months will evaluate the feasibility, safety and effectiveness of self-management within PR according to guideline recommendations as a partial replacement of supervised PR on health outcomes (i.e., adherence, exercise capacity, MRC dyspnea score, health related quality of life, disease burden, lung attacks), and the predictive validity of the PATCH tool. In addition, implementation will be evaluated in terms of perceived feasibility and acceptability of selfmanagement and the PATCH tool by patients and physiotherapists through questionnaires and semi-structured interviews. The study will be conducted in primary physiotherapy practices in the Netherlands. Physiotherapists will be eligible if their practice has access to a computer and internet. Eligible physiotherapists who provide informed consent will be enrolled into the study. Patients with COPD from the participating practices who indicate an interest in participation in the study, will be screened for eligibility by the researcher, and have follow-up measurements at 3, 6, 9 and 12 months from baseline. Physiotherapists and patients are recruited throughout the Netherlands. The design of the study and flow of practices and patients is shown in Figure 1. The protocol is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [20].
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