Schweda, Simone http://orcid.org/0000-0001-5827-2664
Müller, Gerhard
Munz, Barbara
Sudeck, Gorden
Martus, Peter
Dierkes, Katja
Krauss, Inga
Funding for this research was provided by:
Allgemeine Ortskrankenkasse (AOK) Baden-Württemberg
Article History
Received: 10 December 2021
Accepted: 11 May 2022
First Online: 13 June 2022
Declarations
:
: This study has been approved by the Ethics committee of the Medical Faculty of the University of Tuebingen (628/2021BO2). The trial was registered at ExternalRef removed (ID: DRKS00025033) on the 30 September 2021. Participants will be informed about potential harms and benefits of the study and the voluntariness of study participation. Written informed consent will be obtained from all participants prior to the study inclusion. In case of modifications of the protocol an amendment will be sent to the local Ethics committee prior to the implementation.Data privacy is warranted by including different parties to guarantee pseudonymization of patient data derived from different data sources. Each party has a predefined right of access to personal and study data of the participants. All involved parties will sign a contract according to Art 26 DSGVO referring to the joint controllership for data privacy before the inclusion of the first participant.
: Not applicable.
: The non-profit health insurance company and funder of the trial is involved in the trial set-up, data acquisition, conduction of the intervention and data analysis. The Department of Sports Medicine of the Medical Clinic of the University Hospital offers a 2-days education program for exercise instructors for the <i>MultiPill-Exercise</i> intervention. The funder will assess economic outcomes such as direct and indirect health care costs and further evaluates the concept in cooperation with the University Hospital.