the Prevalence of "Wearing-off" in Patients With Parkinson's Disease in Shanghai (shapd-woq)

• ClinicalTrials.gov Identifier: NCT03792204
• Recruitment Status: Completed
• First Posted: January 3, 2019
• Last Update Posted: January 3, 2019
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Information provided by (Responsible Party): Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment
Wearing Off Effect; Parkinson Disease	Diagnostic Test: Wearing-off 9 questionnaire

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 Design

• Study Type: Observational
• Actual Enrollment: 1480 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: the Prevalence of "Wearing-off" in Patients With Parkinson's Disease in Shanghai, China: a Cross-sectional Investigation
• Actual Study Start Date: September 1, 2017
• Actual Primary Completion Date: August 31, 2018
• Actual Study Completion Date: August 31, 2018

Groups and Cohorts

Group/Cohort

Intervention/treatment

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

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.; Other Name: No other intervention

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

clinical diagnosed PD patients

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.

Contacts and Locations

Locations

China, Shanghai

Xinhua hospital affiliated to Shanghai jiaotong university school of medicine

Shanghai, Shanghai, China, 200092

Sponsors and Collaborators

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

• Study Chair: Zhenguo Liu, Ph.D.; Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine

More Information

• Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT03792204
• Other Study ID Numbers: XH-18-011
• First Posted: January 3, 2019
• Last Update Posted: January 3, 2019
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Undecided to make individual participant data available to other researchers

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:

wearing off; wearing-off 9 questionnaire; prevalence; sensitivity; specificity

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases