Müller, Christiane http://orcid.org/0000-0002-7871-0884
Hesjedal-Streller, Berit
Fleischmann, Nina
Tetzlaff, Britta
Mallon, Tina
Scherer, Martin
Köpke, Sascha
Balzer, Katrin
Gärtner, Linda
Maurer, Indre
Friede, Tim
König, Hans-Helmut
Hummers, Eva
Funding for this research was provided by:
Gemeinsamer Bundesausschuss (01VSF16029)
Article History
Received: 13 May 2020
Accepted: 10 September 2020
First Online: 5 November 2020
Ethics approval and consent to participate
: This project has received ethical approval from the ethics committee of the Medical Faculty, Georg-August-University Göttingen, Germany (no. 31/7/17) as well as ethical approval from the ethics committee of the University of Lübeck (no.18-051) and the ethics committee of the University Medical Center Hamburg-Eppendorf (no. MC-304/17). All ethics committees and researcher in the study centres will be informed immediately about any protocol amendments and serious or unexpected adverse events as well as a premature end of the study. Moreover important changes of the protocol are communicated to the funder and have to be agreed on. Modifications of the intervention are expected to be part of the implementation process and are consented and communicated during the kick-off-meetings.Before entering the project, every participating NHR or her/his legal guardian must give written consent. Beforehand, the NHR or her/his legal guardian receives information about the nature and scope of the project in oral and written form by a member of the research team. In particular, the NHR/legal guardian will be informed about the benefit for her/his health and potential risks. The information will be given in a manner NHRs are able to understand.Consent of the NHRs or their legal guardian will be documented by signing the informed consent. Furthermore, nursing home directors must give their written informed consent before the start of the project after being informed orally and in written form.The declaration of consent to participate in the study will be dated and signed by the NHR as well as a member of the research team. One copy of the signed informed consent will be given to the NHR, and the second copy will be kept in the respective study centre.The participation in the main trial and the process evaluation is voluntary for each target person of interest. Consent to participate can be withdrawn by participants at any time without giving reasons and without any detriment for the provision of medical and nursing care.In case of withdrawal, the obtained data will be deleted or the withdrawing participant will be asked to give consent to the analyses of this material.
: Not applicable.
: The authors declare that they have no competing interests.