Vertigo Observation
The Daily Diary phone calls are very important for this study. Because of this we ask that the initial training of how important these phone calls are begins with the pre-screening conversation with the potential subject and continues with detail training at Visit 1.
Let me elaborate on this a bit. We recommend that the SC/PI have the following conversation with the potential subject during the pre-screening conversation. “In this study it is required that you make Daily Phone calls every night for the entire duration of the study, which is approximately four months long. You will be asked if you had any Vertigo episodes that day, and if so how many and to rate the severity of your worst Vertigo episode you had on that day and how that episode effected your day. You will receive a toll-free phone number to call and we find it …show more content…
This training should include;
1. Review with the subject the “Subject Call and Instruction Guide” and give them it to take home.
2. Review with the subject the “Vertigo Instruction Card” and give them it to take home.
• Included in the “Vertigo Instruction Card” is the rating scale for the Vertigo. It is important to thoroughly go over this with the subject in detail, making sure they understand how to rate their Vertigo episodes.
• Have a conversation about making sure that they accurately rate their Vertigo episodes, because this is the important data that is needed for this study.
3. Suggest and perhaps help the subject program the toll-free number into their phone, so they do not have to manually enter it each night.
4. A good suggestion that one of our sites is recommending to their subjects is to set an alarm on their phones that is titled “Make your Vertigo Phone Call”.
5. On the day the subject has completed their Visit 1 procedures, that is the day the SC registers the subject into the ERT system and instructs the subject to start making the phone calls on that same
Let me elaborate on this a bit. We recommend that the SC/PI have the following conversation with the potential subject during the pre-screening conversation. “In this study it is required that you make Daily Phone calls every night for the entire duration of the study, which is approximately four months long. You will be asked if you had any Vertigo episodes that day, and if so how many and to rate the severity of your worst Vertigo episode you had on that day and how that episode effected your day. You will receive a toll-free phone number to call and we find it …show more content…
This training should include;
1. Review with the subject the “Subject Call and Instruction Guide” and give them it to take home.
2. Review with the subject the “Vertigo Instruction Card” and give them it to take home.
• Included in the “Vertigo Instruction Card” is the rating scale for the Vertigo. It is important to thoroughly go over this with the subject in detail, making sure they understand how to rate their Vertigo episodes.
• Have a conversation about making sure that they accurately rate their Vertigo episodes, because this is the important data that is needed for this study.
3. Suggest and perhaps help the subject program the toll-free number into their phone, so they do not have to manually enter it each night.
4. A good suggestion that one of our sites is recommending to their subjects is to set an alarm on their phones that is titled “Make your Vertigo Phone Call”.
5. On the day the subject has completed their Visit 1 procedures, that is the day the SC registers the subject into the ERT system and instructs the subject to start making the phone calls on that same