Ethics Approval, Informed Consent, and Participation
TSD
The study was registered in ClinicalTrials.gov (NCT03705104) and approved by the Regional Committee for Medical and Health Research Ethics (REK 2018/8911) and the Hospital Privacy Protection Committee (ie, institutional review board equivalent; PVO 2017/6697). The study method and results were reported following the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist of information to include when reporting an RCT (All potential participants received information about the nature of the study and details about study participation before deciding whether to participate. All study participants provided written informed consent. The signed consent forms were stored separately from any study data under lock and key in a separate departmental cabinet. Data from questionnaires and outcome measures were collected through the secure TSD platform throughout the study, and all personally identifiable information was deidentified from the TSD database before exporting the study data to a local secure server for further analysis. The participants did not receive compensation for participation in the study.