Table 4.

Difficulties associated with monitoring during the study and related correction measures.

Study activity and associated difficulties or risks		Measures to correct or mitigate
Correct use of the device
	No use	Send notifications encouraging use of the device Call to remind participants and stress the use of the device
	Problems with the server in recording of the data	Perform maintenance of the platform Call to record the daily use if more than 7 days without use
	Defective Fitbit	Provide contact number for technical problems Test devices in advance
	Forget username and/or password	Provide contact number in the instruction book for technical concerns Create database of patients and log-in data Configure the app so that it does not log out the participants
	Problems uploading the Fitbit data	Explain that Bluetooth needs to be enabled for uploading of data; participants should synchronize data every day
Response to the weekly questionnaires
	No response	Send reminders in the form of notifications Review responses from the platform Consider a percentage of 30% as possible dropouts in recruitment
Loss of the patient from the study
	No response to the calls	Consider a percentage of 30% as possible dropouts in recruitment
	Patients reject follow-up	Follow-up call to all patients in the middle of the study to explore difficulties and problems, to encourage, etc