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Authors
Rutsch, Mercedes
Jochems, Nicole
Schrader, Andreas
Brandes, Iris
Weier, Lisa
Deck, Ruth
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Funding
Funding for this research was provided by:
Deutsche Rentenversicherung Bund (0421/40-69-10-12-Lü)
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Article History
Received: 26 March 2020
Accepted: 22 April 2020
First Online: 6 May 2020
Ethics approval and consent to participate
: This study will be performed in accordance with the Declaration of Helsinki. The ethical committee of the University of Lübeck has approved the study (register number: 19–298) on 13. September 2019. Informed consent will be signed by participants. The data protection concept will be implemented according to the current guidelines of the German Pension Insurance (“Deutsche Rentenversicherung Bund”).Before the study starts, all potential participants will be informed in written form about the study, and their signed consent will be requested. The participants of the IG have to agree with the consent for the aftercare programme with ReNaApp before they start the study. Therefore, the documents (patient information sheet, declaration of consent) are prepared in accordance with the guidelines of the DRV data protection officer []. Because of the General Data Protection Regulation (European Union), the participants may contact the competent authority for data protection and the contact person of the respective supervisory authority. With regard to data protection, we refer the study participants to the DRV Bund, which is in charge of this.All personal data are pseudonomised in the rehab clinics and stay password-protected in each clinic. The participants who meet the inclusion criteria and sign their consent will be included in the study. All personal data (questionnaire data) will be pseudonymised in the clinic (using ID numbers). The assignment list (ID number and address) will be kept strictly separate and saved in the questionnaire file. Immediately after completion of the 12-month follow-up and after data control has taken place, this key file will be deleted, and the data will be anonymised. The original documents will be kept in accordance with the Guidelines and Recommendations for Securing Good Epidemiological Practice (GEP) [] for up to 10 years after the end of the study.
: Not applicable because the manuscript does not contain any personal data.
: The authors declare that they have no competing interests.
