the Prevalence of Wearing-off in Patients With Parkinson's Disease in Shanghai

Study Overview
=================
Brief Summary
-----------------
The study would be designed as a multi-center cross-sectional investigation on the prevalence of Wearing-off in Parkinson's patients in Shanghai as well as related influencing factors.

Detailed Description
-----------------
PD patients would be randomly recruited into this investigation from around thirty hospital covering the 16 districts of Shanghai. The wearing off would be defined by two methods: the doctors' judgement or the WOQ-9 questionnaire which was a patient-determining tool. The investigation also includes the medicine, the severity of PD symptoms, the demographic factors. The study would be designed with the purpose of clarifying the prevalence of the wearing-off and its related influencing factors.

Official Title
-----------------
the Prevalence of Wearing-off in Patients With Parkinson's Disease in Shanghai, China: a Cross-sectional Investigation

Conditions
-----------------
Wearing Off Effect, Parkinson Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Wearing-off 9 questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have been clinical diagnosed with Parkinson's disease have received stable anti-Parkinson's treatment before being recruited to the study. Exclusion Criteria: being suspicious of atypical Parkinson syndrome or secondary Parkinson syndromes have not received anti Parkinsonian treatment. being combined with serious cognitive dysfunction or psychiatric symptoms unable to complete the investigations.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD patients with wearing-off effect<br>people who have been clinically diagnosed with Parkinson's disease (PD) and have received anti PD therapy would be recruited into the study. The anti -PD treatment would not be changed in the population of the participants. We would use the tool of 'Wearing-off 9 questionnaire' to determine the prevalence of Wearing-off phenomenon in Parkinson's patients in Shanghai | Diagnostic Test: Wearing-off 9 questionnaire<br>* The participants would receive appropriate anti-PD medical treatments according to the patients' need during the investigation.The anti -PD treatment would not be changed in the population of the participants.<br>* Other names: No other intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China | every participant receives a clinical assessment of the wearing-off symptoms by a physician and completes a self rating scale of the wearing-off 9 questionnaire (WOQ-9) to obtain a prevalence of wearing-off positive individuals( wearing-off would be diagnosed by physicians during the clinical assessments) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the sensitivity and the specificity of the wearing-off 9 questionnaire in the diagnosis of wearing-off effect in Parkinson's disease. | The physician assessment served as the standard for comparison with the WOQ-9 questionnaire. Sensitivity was defined as the probability that a PD patient, classified as having wearing-off (WO) according to physician assessment, would be classified as having the WO using the WOQ-9 questionnaire. The specificity was defined as the probability that a PD patient without the WO by physician assessments would be classified as being without the WO using the WOQ-9 questionnaire | 1 year | 
| the risk factors of wearing-off in Parkinson disease | assess patients clinical characteristics and medical treatments, including the onset age, disease duration and daily levodopa dosage in the subsets of Parkinson patients with wearing-off diagnosed by physician assessment. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wearing off, wearing-off 9 questionnaire, prevalence, sensitivity, specificity