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Completed

NCT Number: NCT03792204

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

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.

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Key information

Conditions

Wearing Off Effect Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Hypersensitivity Immune System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinhua hospital affiliated to Shanghai jiaotong university school of medicine

Shanghai, Shanghai Municipality, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wearing-off 9 questionnaire

Diagnostic Test

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 names: No other intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: shapd-woq

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 3, 2019
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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