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Authors
Dehl, Terese
Sauerbrey, Ulf
Dreier-Wolfgramm, Adina
Nikelski, Angela
Chikhradze, Nino
Keller, Armin
Laufer, Jessica
Schumacher-Schoenert, Fanny
Kreisel, Stefan
Thyrian, Jochen René
Hoffmann, Wolfgang
Vollmar, Horst Christian http://orcid.org/0000-0002-0117-7188
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Funding
Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (The funding codes (FKZ) are 01GL1701A (German Center for Neurodegenerative Diseases / 607 site Rostock/Greifswald, Greifswald); 01GL1701B (Evangelisches Klinikum Bethel, Division of Geriatric Psychiatry, Bielefeld); 01GL1701C (Institute of General Practice, Faculty of Medicine, Bochum); 01GL1701D (Institute of Community Medicine, Department of Epidemiology and Community Health, Greifswald)., The funding codes (FKZ) are 01GL1701A (German Center for Neurodegenerative Diseases / 607 site Rostock/Greifswald, Greifswald); 01GL1701B (Evangelisches Klinikum Bethel, Division of Geriatric Psychiatry, Bielefeld); 01GL1701C (Institute of General Practice, Faculty of Medicine, Bochum); 01GL1701D (Institute of Community Medicine, Department of Epidemiology and Community Health, Greifswald).)
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Article History
Received: 27 May 2020
Accepted: 5 January 2021
First Online: 21 January 2021
Ethics approval and consent to participate
: The study is conducted in accordance with the criteria (valid at present) of the Declaration of Helsinki, the ICH guidelines for Good Clinical Practice, the Memorandum for Safeguarding Good Scientific Practice (German Research Foundation/DFG), the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS/WHO), and the CONSORT Statement of recommendations for reporting trials. An independent advisory board is established including Patient and Public Involvement (PPI) representatives as well as scientific experts that also review the adherence to the abovementioned guidelines during the entire course of the study.Only subjects who provide valid written informed consent will be included. Thus, prior to participation, all participants will receive oral and written information on the study, including information on data protection procedures and potential risks and benefits. Since an inclusion criterion for our study is cognitive impairment, there is an algorithm in place to obtain valid informed consent. In case of incapability of giving informed consent, the legal representative and/or the informal caregiver will be asked in addition to the PCI.Ethical approval for this trial was obtained from the Ethical Committee of the University Medicine Greifswald (Registry number: BB 159/17) and the Ethical Committee of the Medical Chamber Westphalia-Lippe (Registry number: 2017-688-b-S). The trial is registered at ClinicalTrials.gov (NCT03359408). The results will be published according to the guidelines of The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation). The approximate date when recruitment to the process evaluation of the study will be completed is 31 May 2021.
: Not applicable.
: The authors declare that they have no competing interests.
