Lüth, Frederike
Weber, Clarissa Elisabeth
Kortkamp, Christian
Steyer, Linda
Müller, Christiane Annette
Tetzlaff, Britta
Mazur, Ana Lucia
Kühn, Anja
Scherer, Martin
Köpke, Sascha
Friede, Tim
Hummers, Eva
Maurer, Indre
Balzer, Katrin
Funding for this research was provided by:
Universität zu Lübeck
Article History
Received: 2 August 2024
Accepted: 23 February 2026
First Online: 7 March 2026
Declarations
:
: The interprof ACT trial received ethical approval from the ethical committee of the Medical Faculty, Georg-August-University, Göttingen (no. 31/7/17), the ethical committee of the University of Lübeck (no. 18–051), and the Ethics Committee of the Medical Association of Hamburg-Eppendorf (no. MC-304/17). First, the facility director of the nursing home signed written consent to participate in the interprof ACT trial after being informed about the study orally and in written form. Second, NHRs or their legal guardians had to provide written consent to participate in the interprof ACT trial. Therefore, the NHR and/or legal guardian received oral and written information about the study and its procedures as well as about the benefits for residents’ health and potential risks. The information was written in a language that was easy to understand and included information about the data to be collected from/about the NHR, either via data extraction from the NHR chart (main trial only) or structured oral face-to-face interviews (main trial and process evaluation). The NHRs and/or legal guardians subsequently provided informed consent. Before starting each face-to-face interview, a member of the research team repeated this information orally, confirming the NHRs’ willingness to participate. Similar to the data extracted from the NHRs’ charts, the interview data were collected in a pseudonymized manner based on a separate code list. For all target populations, informed consent was necessary for participation in any quantitative inquiry for the process evaluation if the data were not collected anonymously (RN, GP, and IPAV questionnaires). Written information about the scheduled surveys was included on the cover page of each questionnaire (except for the NHRs’ questionnaire), and the completion of these questionnaires was regarded as written informed consent. At each kick-off meeting, all attendees were asked to confirm their participation in person on a list. These participant lists were saved electronically at the local study center separately from all of the other trial documents and were accessible only to the members of this local study team. All target groups of the qualitative strand of the process evaluation had to provide written consent to participate after they received detailed information about the qualitative process evaluation and data collection methods. Before each follow-up interview or observation, the study was explained again, and participants were given the opportunity to reconsider their consent. Participation in the interprof ACT trial and the embedded process evaluation were voluntary and could be withdrawn at any time point in the study without the participants providing a reason or consequences for medical/nursing care. If individuals withdrew their consent, they were asked to provide consent for the analyses of the already collected data. If a person refused consent for these analyses, the collected data were deleted immediately. An exception is data that were collected anonymously and that have already been aggregated and published.
: Not applicable.
: The authors declare no competing interests.