Restless Legs Syndrome Clinical Trial
Official title:
Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs
The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care
practices in Germany. The study will be conducted on a fixed day in November 2007.
Primary care surgeries throughout Germany will be asked to take part. The study material
will be delivered to the surgery by a member of sales-force who will also explain the study
conduct to the physician/staff. Physicians who want to take part in the study will send a
signed contract to BI. Physicians will be trained to diagnose RLS.
All patients attending the participating surgeries on a fixed day will be invited to
participate in the study. The patients will be handed a questionnaire to fill out while
waiting for their appointment. No patient-related data apart from gender and year of birth
will be recorded on the questionnaire and it will be ensured that no re-identification of
patients is possible. Therefore, no written informed consent will be obtained from the
participants.
The patient questionnaire will consist of the following items:
A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file)
Additional questions concerning the impact of the patients leg problems on daily life.
The practice staff will then collect the questionnaire. All patients who have answered
question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be
assessed for the diagnosis by the physician.
The physician fills out a second questionnaire, covering the following items:
Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of
RLS was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed
questionnaires will be sent to data management by the surgery within 2 working days.
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