Baroni Caramel, Vanusa M. http://orcid.org/0000-0002-1921-0951
van der Steen, Jenny T. http://orcid.org/0000-0002-9063-7501
Vink, Annemieke C. http://orcid.org/0000-0003-4242-4314
Janus, Sarah I. M. http://orcid.org/0000-0003-0419-4407
Twisk, Jos W. R. http://orcid.org/0000-0001-9617-1020
Scherder, Erik J. A. http://orcid.org/0000-0003-1203-3208
Zuidema, Sytse U. http://orcid.org/0000-0002-4991-9507
Article History
Received: 8 December 2022
Accepted: 1 March 2024
First Online: 27 March 2024
Declarations
:
: The first (VMBC) and fourth (SIMJ) authors will have access to the full dataset in Redcap. The anonymized data that support the findings of this study will be available upon reasonable request from the corresponding author. The data will not be publicity available due to privacy or ethical restrictions.
: “This study was conducted according to the guidelines laid down in the declaration of Helsinki. Ethical approval was obtained from the Medical Ethics Review Board of the university medical center of Groningen (UMCG) in the context of the Medical Research Involving Human Subjects Act (WMO). The review board reference number is METc 2019/021. An informed (proxy) consent is obtained for all participants. Participation in the study will be voluntary. Participants or legal representatives can withdraw consent at any time. Any attrition or adverse effects of the intervention or control group will be documented. In addition to sessions immediately stopped in the case of adverse reactions, the interventions will be discontinued if, in consultation with the physician or psychologists, harmful effects are observed and are expected to continue with exposure to any of the two interventions. The trial is registered at the International Clinical Trials Registry Platform (ICTRP) search Trial Registration number NL 7708 (ExternalRef removed” in the Ethics approval and consent to participate section.
: Not Applicable.
: The authors declare that they have no competing interests.
: The first author (VMBC) provides an information letter with informed consent form to competent residents and to the legal representatives of non-competent eligible residents. All information sheets and consent forms were be written in Dutch. First author will discuss the trial with patients or legal representatives and then obtain consent when willing to participate in the trial.
: All study-related information will be stored securely at the study site. All participant information will be stored in locked file cabinets in areas with limited access. All files are confidential and coded with a 5-number code. The coding list is stored in a record cabinet with a key that only the first author can access.