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Article History

Received: 8 August 2022

Accepted: 11 September 2023

First Online: 26 September 2023

Declarations

:

: This trial has been approved by Hospital de Clínicas de Porto Alegre Ethics Committee/IRB (48869621900005327), and it is registered at ClinicalTrials.gov (NCT05258526), prior to the beginning of the study. The informed consent forms (remote and face-to-face) include the study’s objectives, description of the testing procedures, explanation about the intervention, the potential risks and benefits involved in the study, the costs to the participants and information on anonymized data sharing. The investigator in charge of providing study clarifications and seeking the participant’s ethical consent should send the remote informed consent form in advance, allowing the patient sufficient time to read, ask questions and decide to participate or not in the trial. If the patient does not agree or does not have a literacy in e-mailing, text messaging, and other forms of remote contact, by the time of the face-to-face interaction with the research team, there will be given enough time for the patient to read and ask questions, deciding whether or not to participate in the trial. It is important to notice that, if for the patients who have agreed to the remote consent form, at the time for the face-to-face evaluations, a paper signed consent form should be obtained. Once a patient decides to participate, a signed and personally dated informed consent is obtained from the patient before any trial-related procedure. A copy of the consent form is given to the participant (electronic and paper), and these procedures are documented in the patient’s record.

: Not applicable.

: The authors declare that they have no competing interests. The funders had no role in the design of the study at any stage.