Confidentiality
Participants are added to a password-protected study list (Microsoft Excel) with their name, address, and social security number upon consent to participate and are assigned an identification number. This list also documents the treatment group, consent, and the planned start of rehabilitation after randomization. This study list remains at the recruiting rehabilitation center. The rehabilitation center transmits a pseudonymized copy of this list exclusively with the pseudonym, treatment group, date of receipt of consent and planned start of rehabilitation electronically and encrypted to the University of Lübeck at the beginning of each week. The study list will be shredded by the rehabilitation center after all follow-up questionnaires have been sent out. As of that point, the data will be completely anonymized.The rehabilitation center documents in another list (Microsoft Excel), in which participants are recognized only by their identification number (pseudonymized list), their date of birth, gender, the actual start of rehabilitation and the end of rehabilitation (if necessary, also the early termination of rehabilitation), selected clinical data collected in the rehabilitation center (systolic and diastolic blood pressure, ergometer performance in watts/kg, capacity for last job and other job, recommendations for subsequent services, diagnoses), and the therapeutic services performed during rehabilitation.The participants’ questionnaires are provided with the identification number in the rehabilitation center and handed over to the study participants by a member of the research team for completion at the beginning and end of the rehabilitation. The participants deliver the questionnaires in an envelope at the reception of the rehabilitation center. Thereafter, these questionnaires are personally handed over to MB by DB every two weeks. The questionnaires of the follow-up assessments after 3 and 12 months, also tagged with the identification number, as well as the reminders, are sent from the rehabilitation center. A stamped return envelope addressed to the University of Lübeck is enclosed with this letter.Data, pseudonymized with the identification number, are recorded electronically at the University of Lübeck using Microsoft Access. All questionnaires received by the University of Lübeck are stored in locked cabinets at the University of Lübeck and will be shredded in accordance with data protection regulations upon completion of the study on 28.02.2025. Computers at the University of Lübeck that allow access to the data entered are located in locked office rooms and require user authentication in the form of passwords. Accesses can be tracked. Data is stored in folders that are only visible and accessible to the research team at the University of Lübeck. The network in which the computers are integrated is protected against external access and manipulation by a regularly updated firewall system. The University of Lübeck will completely delete the electronically stored questionnaire data 10 years after the end of the study (28.02.2035). To ensure a transparent research process, anonymized data will be permanently stored in a data repository after our primary publication is accepted (