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

Parkinson Disease Clinical Trial

— shapd-woq  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792204
• Other study ID #: XH-18-011
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1480
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Wearing Off Effect

Intervention

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.

Locations

Country	Name	City	State
China	Xinhua hospital affiliated to Shanghai jiaotong university school of medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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