Hoffmann, Mariell http://orcid.org/0000-0003-3303-7478
Stengel, Sandra
Forstner, Johanna
Baldauf, Annika
Laux, Gunter
Aluttis, Frank
Qreini, Markus
Engeser, Peter
Szecsenyi, Joachim
Peters-Klimm, Frank
Funding for this research was provided by:
AOK Baden-Württemberg (not applicable)
Universitätsklinikum Heidelberg
Article History
Received: 26 May 2021
Accepted: 19 July 2021
First Online: 2 September 2021
Declarations
:
: The study is being conducted in accordance with the Helsinki Declaration (2013). This trial has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (reference number: S-266/2020).Names of patients and other study participants and all other confidential information are subject to medical confidentiality and the regulations of the General Data Protection Regulation. Patient data is passed only in pseudonymized form. No third parties gain insight into original data.All participants will be informed about aims, content, duration and process of the study, particularly as far as risks and unintended consequences are concerned, through written information leaflets and through telephonic communication with the responsible physician or staff of the study central office for the process evaluation. Agreement for study participation is confirmed by signing the consent form.Patients who are unable to give their informed consent, in this case for example people with cognitive impairment such as dementia, can participate in this study if a legal representative gives his informed consent for the patient to participate in this study. Recently, the number of outbreaks in retirement and long-term institutions in Germany, where many of the residents are affected by cognitive impairment, increased. The treating physician usually is the GP. Therefore, people with cognitive impairment should not be excluded from study participation.Study participation for patients and healthcare providers is voluntary. The consent can be withdrawn by the patient/participant at any time without declaration of reasons and without any disadvantages concerning their further medical care. Data already collected at the time of withdrawal of consent will be destroyed or can be analyzed with the agreement of the participant to do so.
: A model consent form will be provided on request.
: The authors declare that they have no competing interests.