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

Completed

• Conditions: Parkinson Disease; Wearing Off Effect

• 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.

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-22
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Study First Submitted QC: 2019-01-01
• Last Update Submitted: 2019-01-01
• Study First Posted: 2019-01-03
• Last Update Posted: 2019-01-03

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

Primary Outcome Measures

Name	Time	Method
the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China	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 Outcome Measures

Name	Time	Method
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 disease	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.

Trial Locations

Locations (1)

Xinhua hospital affiliated to Shanghai jiaotong university school of medicine; 🇨🇳 Shanghai, Shanghai, China