Could the destinction between early morning coughing and rest of day coughing be clarified: how would the patients be asked to differentiate between immediately upon rising vs. rest of day?
The typical early morning coughing starts as soon as (within a couple of minutes of) them waking up or getting up and is almost always productive. Anything else is rest of the day. Patients with the typical early morning cough can usually easily distinguish the two types.
What happens if a subject loses the smartphone device?
If a subject loses their device, they should be given a replacement. The subject will just need to log onto the new device with the same email address and password/PIN used on their initial device. If needed, contact the study team to request a replacement device.
Can subjects set an alarm on the device to remind them to complete the diary?
No. The alarm function will not be enabled on the devices, but daily reminders/notifications will be automatically generated.
Are reminders for eDiary completion sent to subjects?
Yes, reminders to complete the questionnaires are sent automatically every day. They are similar to standard notifications that are sent to smartphones. Subjects will receive a notification at 9pm in the evening each day (2 hours after the diary becomes available for completion) and and again at 10pm if the diary has still not been […]
Can subjects use their own device/smartphone?
Only provided devices can be used at this time.
Is there a helpline for subjects/staff in case of technical difficulties with the ePRO devices?
Yes, there is a 24-hour helpdesk available. Details are provided both on the device itself and in the user guides.
Are self-reported cough scale scores via the eDiaries available for review in real-time for eligibility purposes?
Sites are not able to view the subject’s responses to the cough scales. Monitors and the Sponsor/CRO clinical team will not be able to view the responses either. This design is best practise to avoid any influence over the subject’s scores. Eligibility will only be confirmed when the subject comes to the site for Visit […]
