Swart, Myrthe M
Smetsers, Ligaya
Bautmans, Ivan
Plácido da Silva, Hugo
Geerds, Merle
Tielemans, Rudi
Melis, René
Peeters, Geeske
Funding for this research was provided by:
Active and Assisted Living Programme (AAL-2020-7-237-CP, AAL-2020-7-237-CP, AAL-2020-7-237-CP, AAL-2020-7-237-CP, AAL-2020-7-237-CP, AAL-2020-7-237-CP, AAL-2020-7-237-CP)
Article History
Received: 5 April 2024
Accepted: 14 August 2024
First Online: 24 August 2024
Declarations
:
: The Geriatric Resilience Registry (protocol number 2021-13022) was reviewed by the research ethics committee of the Radboud university medical center and falls outside the remits of the Medical Research Involving Human Subjects Act. The main aim of FORTO is to develop and evaluate the Eforto® device in clinical settings. Therefore, the Medical Device Regulations apply. FORTO was reviewed by the East Netherlands Research Ethics Committee (METC Oost-Nederland, protocol number NL77879.091.21)). The ethics committee approved the study based on the Dutch Code of Conduct for Health Research, the Dutch Code of Conduct for Responsible Use, the Dutch Personal Data Protection Act, and the Medical Treatment Agreement Act. All participants provided oral informed consent, and all participants taking part in repeated daily measurements provided written informed consent as required by Dutch regulations.
: Not applicable.
: Uniweb is the manufacturer of the Eforto® device. Uniweb has contributed to the development of the device and platform. The data collection, analysis, and reporting were fully in the hands of researchers working at Radboudumc.