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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03792204
Acronym
shapd-woq
Enrollment
1480
Registered
2019-01-03
Start date
2017-09-01
Completion date
2018-08-31
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Wearing Off Effect

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTWearing-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.

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China1 yearevery 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

MeasureTime frameDescription
the sensitivity and the specificity of the wearing-off 9 questionnaire in the diagnosis of wearing-off effect in Parkinson's disease.1 yearThe 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 yearassess 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026