<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03792204</url>
  </required_header>
  <id_info>
    <org_study_id>XH-18-011</org_study_id>
    <nct_id>NCT03792204</nct_id>
  </id_info>
  <brief_title>the Prevalence of &quot;Wearing-off&quot; in Patients With Parkinson's Disease in Shanghai</brief_title>
  <acronym>shapd-woq</acronym>
  <official_title>the Prevalence of &quot;Wearing-off&quot; in Patients With Parkinson's Disease in Shanghai, China: a Cross-sectional Investigation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study would be designed as a multi-center cross-sectional investigation on the prevalence&#xD;
      of Wearing-off in Parkinson's patients in Shanghai as well as related influencing factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PD patients would be randomly recruited into this investigation from around thirty hospital&#xD;
      covering the 16 districts of Shanghai. The wearing off would be defined by two methods: the&#xD;
      doctors' judgement or the WOQ-9 questionnaire which was a patient-determining tool. The&#xD;
      investigation also includes the medicine, the severity of PD symptoms, the demographic&#xD;
      factors. The study would be designed with the purpose of clarifying the prevalence of the&#xD;
      &quot;wearing-off&quot; and its related influencing factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China</measure>
    <time_frame>1 year</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the sensitivity and the specificity of the wearing-off 9 questionnaire in the diagnosis of wearing-off effect in Parkinson's disease.</measure>
    <time_frame>1 year</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the risk factors of wearing-off in Parkinson disease</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1480</enrollment>
  <condition>Wearing Off Effect</condition>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>PD patients with wearing-off effect</arm_group_label>
    <description>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.&#xD;
We would use the tool of 'Wearing-off 9 questionnaire' to determine the prevalence of Wearing-off phenomenon in Parkinson's patients in Shanghai</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Wearing-off 9 questionnaire</intervention_name>
    <description>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.</description>
    <arm_group_label>PD patients with wearing-off effect</arm_group_label>
    <other_name>No other intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        clinical diagnosed PD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have been clinical diagnosed with Parkinson's disease&#xD;
&#xD;
          -  have received stable anti-Parkinson's treatment before being recruited to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being suspicious of atypical Parkinson syndrome or secondary Parkinson syndromes&#xD;
&#xD;
          -  have not received anti Parkinsonian treatment.&#xD;
&#xD;
          -  being combined with serious cognitive dysfunction or psychiatric symptoms&#xD;
&#xD;
          -  unable to complete the investigations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhenguo Liu, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xinhua hospital affiliated to Shanghai jiaotong university school of medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wearing off</keyword>
  <keyword>wearing-off 9 questionnaire</keyword>
  <keyword>prevalence</keyword>
  <keyword>sensitivity</keyword>
  <keyword>specificity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided to make individual participant data available to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03792204
org study id: XH-18-011
nct id: NCT03792204
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China
time frame: 1 year
description: 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)
measure: 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
description: 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
measure: the risk factors of wearing-off in Parkinson disease
time frame: 1 year
description: 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.
arm group label: PD patients with wearing-off effect
description: 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
intervention type: Diagnostic Test
intervention name: Wearing-off 9 questionnaire
description: 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.
arm group label: PD patients with wearing-off effect
other name: No other intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 90 Years
healthy volunteers: No
last name: Zhenguo Liu, Ph.D.
role: Study Chair
affiliation: Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided
ipd description: Undecided to make individual participant data available to other researchers