the Prevalence of “Wearing-off” in Patients With Parkinson’s Disease in Shanghai

Overview

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.

Full Title of Study: “the Prevalence of “Wearing-off” in Patients With Parkinson’s Disease in Shanghai, China: a Cross-sectional Investigation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: August 31, 2018

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.

Interventions

  • Diagnostic Test: Wearing-off 9 questionnaire
    • 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.

Arms, Groups and Cohorts

  • PD patients with wearing-off effect
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • the prevalence of wearing off effect in Parkinson’s patients that received stable anti Parkinsonian therapy in Shanghai of China
    • Time Frame: 1 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 Measures

  • the sensitivity and the specificity of the wearing-off 9 questionnaire in the diagnosis of wearing-off effect in Parkinson’s disease.
    • Time Frame: 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 disease
    • Time Frame: 1 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhenguo Liu, Ph.D., Study Chair, Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine

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