Table 3.
Difficulties associated with activities of the in-person visit and their correction measures.
Study activity and associated difficulties or risks | Measures to correct or mitigate | |
Presentation protocol and signing informed consent |
|
|
|
Participants decide not to participate | Summarize by phone so that they can assess whether to participate (avoid visit if uninterested) |
Participants do not understand the function | Explain in a simple and clear way the protocol and benefits (eg, “measure your sleep...”) | |
Patient questionnaires |
|
|
|
Patients do not meet the inclusion criteria | Clearly specify the criteria and instruments when explaining the protocol and review medical history |
Download of the app |
|
|
|
Lack of storage space on phone | Forewarn the participant before the visit that an app will need to be downloaded |
Instructions of use |
|
|
|
Misuse of the app or device | Deliver a clear, visual instruction notebook in the first session Rehearse app use during the visit with patient Provide contact information to call in case of difficulties |
Explaining the follow-up |
|
|
|
Participants forget to respond to questionnaires | Prepare a specific calendar for the patients, showing schedule of days to respond to the questionnaires, and schedule a date for the second in-person visit |
|
Participants forget to wear the device daily | Send weekly reminders |