Document is current

Article History

Received: 20 January 2021

Accepted: 27 April 2021

First Online: 12 July 2021

Declarations

:

: 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 above-mentioned guidelines during the entire course of the study. Only participants who provide valid written informed consent were included. Thus, prior to participation, all participants received oral and written information on the study, including information on data protection procedures and potential risks and benefits. Since the inclusion criteria for our study are 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 person with cognitive impairments. Ethical approval for this trial has been obtained from the ethics committee of Greifswald Medical School (registry number: BB 159/17) and the ethics committee of the Chamber of Physicians of Westphalia-Lippe (registry number: 2017–688-b-S). The intersec-CM trial is registered atExternalRef removed(registration number: NCT03359408, date of registration: 02.12.2017).

: Not applicable.

: The authors declare that they have no competing interests.