Mueller-Stierlin, Annabel S. http://orcid.org/0000-0003-2812-5115
Röhrig, Jeanette
Goetzl, Christian
Krausz, Michael
Lehle, Jutta
Prestin, Elke
Schoch, Vanessa-Emily
Sutter, Lorenz
Westenberg, Jean
Cabanis, Maurice
Funding for this research was provided by:
Federal Joint Committee (01NVF19016)
Universität Ulm
Article History
Received: 10 February 2022
Accepted: 23 April 2022
First Online: 1 June 2022
Declarations
:
: This study protocol and its two amendments were approved by the local Ethics Committee at the Landesärztekammer Baden-Württemberg on 4 March 2021, 23 March 2021 (amendment for sub-studies prior to implementation) and 7 October 2021 (amendment for the scales used to assess the secondary outcomes in the randomized controlled trial) (application number: F-2020-171).All participants will be asked to provide written informed consent if they agree to participate in this study. The informed consent form describes the objective of the study and the study procedures for participants. Moreover, details are given on pseudonymization, voluntariness, risks, insurances, confidentiality and incentives. Special attention is paid to the data management, data storage and data protection. A detailed explanation of the intervention is available to the participants if they request, which is also written in layman’s terms. Contact data of the research team, the sponsoring team and data protection officers are made available to the participants. Informed consent and additional information forms are available in German from the corresponding author upon request.
: Not applicable.
: All authors declare that they have no competing interests.The project is funded by the Innovation Committee from the Federal Joint Committee (G-BA), grant number 01NVF19016 (ASSIST). The Federal Joint Committee (G-BA) is the highest decision-making body of the joint self-government of physicians, dentists, hospitals, and health insurance funds in Germany.