Document is current

Article History

Received: 19 January 2021

Accepted: 30 November 2021

First Online: 6 January 2022

Declarations

:

: The Medical Research Ethical Committee Erasmus MC approved this study protocol on November 8th, 2019 (MEC number: MEC-2019-0671). The trial will be conducted in accordance with the principles that have their origin in the Declaration of Helsinki 1996 and the principles of Good Clinical Practice.Amendments are changes made to the research during the research project. The Institutional Review Board will be notified of all substantial amendments and the amendments are subject to approval.All potential participants will be provided with oral and written information about the study from the NP. In the written information folder, patients will receive information about the aims of the study, data protection, and the possibility of withdrawal from the study without explanation. Potential participants will receive time to consider participation and the possibility to ask questions to the NP and researchers. This information and contact details of the researchers are provided to potential participants. If patients want to participate, they will sign an informed consent form and return this to the NP. The NP will inform the researchers by filling in a registration form via the data capture application LimeSurvey. After the registration is completed, the researcher will send the questionnaire to the participants.Participants can leave the study at any time for any reason if they wish to do so without any consequences. The researcher can decide to withdraw a participant from the study for urgent medical reasons. The NP can inform the investigator by filling out the unsubscribe form via LimeSurvey in case participants wish to withdraw, in case of urgent medical reasons or when the participant has died.At the end of the study, all participants will receive a summary of the results and will be notified about this in advance. The professionals involved in the study will also receive a summary of the results and will be invited to a meeting in which the results will be presented by the coordinating investigator. Articles resulting from the trial will be submitted to peer-reviewed journals.The study will use valid and reliable measurement tools derived from previous research and published literature to test the primary and secondary outcomes. This will enhance the validity and reliability of the study.

: Not applicable.

: No conflict of interest has been declared by the authors.