Giovanazzi, Alexia
Gios, Lorenzo
Mastellaro, Marina
Gentilini, Maria Adalgisa
Valent, Francesca
Condini, Sara
Bincoletto, Giorgia
Bacchiega, Alessandro
Zorzi, Andrea
Malfatti, Giulia
Perini, Francesca
Eccher, Claudio
Marchesoni, Michele
Dall’Alda, Marlene
Orrasch, Massimo
Conforti, Diego
Inchiostro, Sandro
Funding for this research was provided by:
Department of Health of the Italian National Health System (NET-2018-12367206)
Provincia Autonoma di Trento
Article History
Received: 11 December 2022
Accepted: 16 July 2023
First Online: 10 August 2023
Declarations
:
: The protocol and the informed consent form, along with other materials (such as App education material, the case report forms, the questionnaires to be filled in by the participants), were reviewed and approved by the Local Ethics Committee for Clinical Trials of the Healthcare Trust (APSS) of the PAT (Rep. Int. 9453–30/05/2022; project ID: A765 and Rep. Int. 17489 -11/10/2022; project ID: ES463). In September 2022, an amendment was requested for two inclusion criteria to be removed. The Local Ethics Committee has requested to be informed about the start and the end of the study, or of its early termination. The principal investigator will have to make an annual report regarding the progress of the study.
: The informed consents (participation to the study and data protection consent) have been translated and are available upon request in Italian and English.
: The authors declare that they have no competing interests.