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
best if you include this nightly phone call in your night time routine, when you brush your teeth and take your night time medication to make your phone call then. That way it becomes routine and easier to remember. If you have not made your night time phone call by 9:00 pm the system will automatically call you to remind you. The good thing about these phone calls is that they only take a few minutes to make and will hopefully become part of your normal night time routine.”

Then at Visit 1 we would like the SC to train the subject.
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
evening.
• In this study the “28 day lead-in” period starts once ALL the Screening procedures have been performed. It is highly preferred to have ALL the Screening procedures done at Visit 1.
• However we know sometimes this may not be possible due to staff schedule. For instance the site Audiologist is not available the same day that the PI is available, what do you do? The site could choose to complete all the Screening Procedures for Visit 1 except for the Audiology procedures and have the Audiology procedures done later in the week. This is why we have a “14 Day Screening Window” in this protocol for circumstances like this.
• But remember there is ONLY 14 days and no exceptions to have ALL the Visit 1 procedures completed. Once ALL these procedures are completed that is when the site instructs the subject to start calling in for their Daily Calls. The preference is to have this all done on Visit 1 and have the subject start making their nightly calls the same day as Visit 1.
• The Daily Dairy phone calls do not start when the subject feels like starting them. This is why the pre-screening conversation is important to have, so the subject will know exactly when they are required to start making the calls.