Subject Instructions
Bring this diary and any unused study medication with you to your next clinic visit Enter the information in the diary every day as required Print neatly and legibly Use ink, preferably black, to complete the information in the diary If you make a mistake: Draw a single line through the incorrect entry and write the correct data nearby Do not "write over" or erase an incorrect entry Do not use correction materials, such as correction fluid or tape, on this diary Page 2 FINAL - 24 SEP 04 If you have questions or concerns, contact the study contact person listed on the front of the diary
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Patient global improvement scale instrucitons
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You will take 2 doses of study medication every day. You should generally take your first dose 1 hour prior to when your RLS symptoms usually start. Your second dose should be taken at bedtime and at least 3 hours after the first dose. You should try to take your second dose within 6 hours of the first dose, as longer time frames between doses (e.g., 8 hours or more) may lead to the reoccurrence of RLS symptoms.
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Dosing information
Dosage given:___________ Tablet x ___________ mg
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Date and time of dosing
datetime
dose administered by
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Dose checked and witnessed by
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Comments
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Patient rated scale
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
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If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
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If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
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If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
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DOSING DETAILS
You will take 2 doses of study medication every day. You should generally take your first dose 1 hour prior to when your RLS symptoms usually start. Your second dose should be taken at bedtime and at least 3 hours after the first dose. You should try to take your second dose within 6 hours of the first dose, as longer time frames between doses (e.g., 8 hours or more) may lead to the reoccurrence of RLS symptoms
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Dosage given:___________ Tablet x ___________ mg
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Date and time of dosing
datetime
dose administered by
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Dose checked and witnessed by
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Comments
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Actigraphy Information
(to be completed by study coordinator prior to giving diary to patient e.g. Monday, Tuesday)
date
Was the device with the "Right" label worn on Right leg Actigraphy Information
boolean
Was the device with the "Left" label worn on Left leg Actigraphy Information
boolean
AM or PM (circle one)
time
____ AM or PM (circle one)
time