Participatory research protocol
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A protocol describing the process of co-creation in developing and testing the RECONNECTED support system. The steps included in the protocol are: (1) planning the purpose of the co-creation, (2) conducting, what activities can be used during co-creation and how can commitment be ensured, (3) evaluation, how to know that the process and the outcome are valid and effective, and (4) reporting, how to report the findings.
Midterm recruitment report RECONNECTED CEMA study
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The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.
Study initiation package RECONNECTED CEMA study
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The study initiation package includes: the registration number of the clinical study in a registry meeting WHO registry criteria, the final version of the protocol as approved by the ethics committees, regulatory and ethics approvals required for the enrolment of the first study participant.