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Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

Primary Purpose

Restless Legs Syndrome

Status

Completed

Phase

Locations

Germany

Study Type

Observational

Intervention

About this trial

This is an observational trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients attending one of the participating primary care surgeries on a fixed day
Male or female patients of any age

Exclusion Criteria:

Patients who only attend the practice to get a prescription and are not seen by the doctor on that day.
Patients who are not able to understand the questionnaire due to mental impairment or language problems.
Children and adolescents under the age of 18 years

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00557258

First Posted

November 9, 2007

Last Updated

February 12, 2009

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00557258

Brief Title

Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

Official Title

Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

Study Type

Observational

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

7. Study Design

Enrollment

14956 (Actual)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients attending one of the participating primary care surgeries on a fixed day Male or female patients of any age Exclusion Criteria: Patients who only attend the practice to get a prescription and are not seen by the doctor on that day. Patients who are not able to understand the questionnaire due to mental impairment or language problems. Children and adolescents under the age of 18 years

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name