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

Completed
Conditions
Parkinson Disease
Wearing Off Effect
Interventions
Diagnostic Test: Wearing-off 9 questionnaire
Registration Number
NCT03792204
Lead Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1480
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PD patients with wearing-off effectWearing-off 9 questionnairepeople 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
Primary Outcome Measures
NameTimeMethod
the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China1 year

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)

Secondary Outcome Measures
NameTimeMethod
the sensitivity and the specificity of the wearing-off 9 questionnaire in the diagnosis of wearing-off effect in Parkinson's disease.1 year

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

the risk factors of wearing-off in Parkinson disease1 year

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.

Trial Locations

Locations (1)

Xinhua hospital affiliated to Shanghai jiaotong university school of medicine

🇨🇳

Shanghai, Shanghai, China

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