The National Registry Study For the Real-world Patients With Parkinsonian Disorders in China

NCT ID: NCT03649503

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2033-09-30

Brief Summary

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The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in this study. Participants will enroll through a platform named PaWei, and provide informed consent prior to any study activities. PaWei will collect a variety of information, including participants' demographic information, overall health, family history of Parkinson's Disease, other clinical information (clinical drug use, drug efficacy, and comorbid disorders), mood status, sleep, diet, exercise, memory complaints, online cognitive tests, the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8), Movement Disorder Society-Unified Parkinson's Disease Rating Scale IB \& II (MDS-UPDRS IB \& II), Non-Motor Symptom Aassessment Scale for Parkinson's Disease (NMSS) , Hoehn and Yahr Scale, and other scales related to quality of life, etal---all through self-reported online questionnaires. Participants will also be asked to return to the PaWei every 3 months at regular intervals, to complete follow-up scales related to quality of life, and neuropsychological assessments, etal. Anyone with Parkinsonian Disorders is welcome to participate.

Detailed Description

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In April 2017, the investigators launched a platform named PaWei which contains an iOS and Android smartphone application for patients and doctors. The platform connects patients, doctors and researchers by establishing communication and data transfer between the cloud platform and the mobile applications over the internet. The PaWei app is made available for free to download through the Apple App Store and Android Market. Through national outpatient service, advertisement and community outreach, potential participants will be directed to the PaWei APP. The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in this study. Participants will enroll through the PaWei APP, and provide informed consent prior to any study activities.

The PaWei APP will include:

1. Information about the National Registry Study (who is eligible to participate, the goals of the project and other relevant information about investigators and sponsors involved in the Initiative).
2. Frequently Asked Questions (FAQs) such as "How will my information be used?", "How will patient information be safeguarded?", "What information will be requested?", "How much time will be required for registration and testing?" will be addressed for participants.
3. General information about Parkinsonian Disorders.

The National Registry Study will be a large, online database of volunteers who are interested in participating in this study. Anyone with Parkinsonian Disorders is welcome to join the Registry.

1. Participants will provide their email address or telephone number and create an account and username with the Registry.
2. The Registry will send an automatic email or short message to the participant to verify their email address or telephone number.
3. Participants will read the online Information Sheet and will be asked to provide their consent by clicking either "I consent" or "I decline." Participants who decline to participate in the Registry will be not included in our study.
4. Participants who give their consent will be permitted to continue through the registration process, which includes completing a battery of questionnaires designed to obtain a general understanding of participants health, medical history wellbeing.
5. In addition to questionnaires, participants will be able to complete online scales related to quality of life, and cognitive assessments.
6. Participants will be given the option to elect a Caregiver and/or Study Partner (CASP) to enrich their study profile.
7. Video recordings: Participants are asked to perform finger tapping, hand movements, and walking in MDS-UPDRS III test after being instructed by the video example, and then to upload the videos to the PaWei APP. The severity of motor dysfunctions on those videos can be judged by clinicians, and be potentially quantified in the future by AI technology under development.
8. Data validation: (1) The quality control of raw data is the initial step of data analysis for any successful research. In PaWei platform, the investigators take a strategy of assessing the data quality by identifying poor-quality data, like incomplete data and illogical data based on the logistic verification about consistency of relevant questions. (2) Automated feedback loops are employed with this strategy to enable real-time detection of incomplete data or illogical data, which can be used to improve data collection quality.
9. Participants may be referred to other research studies and/or clinical trials.

Conditions

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Parkinsonian Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Anyone with Parkinsonian Disorders is welcome to join the Registry.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of the Fourth Military Medical University

OTHER

Sponsor Role collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Changshu Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Guangxi Ruikang Hospital

OTHER

Sponsor Role collaborator

Xi'an Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Jieyang People's Hospital

OTHER

Sponsor Role collaborator

Luoyang Central Hospital

OTHER

Sponsor Role collaborator

Taian City Central Hospital

OTHER

Sponsor Role collaborator

Gansu Provincial Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Daqing Oil Field Hospital

OTHER

Sponsor Role collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

Zhejiang Hospital

OTHER

Sponsor Role collaborator

The 101st Hospital of Chinese People's Liberation Army

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

China-Japan Union Hospital, Jilin University

OTHER

Sponsor Role collaborator

Wuhan No.1 Hospital

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role collaborator

Northern Jiangsu People's Hospital

OTHER

Sponsor Role collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai 5th People's Hospital

OTHER

Sponsor Role collaborator

Third People's Hospital, Huzhou City, Zhejiang Province, China

OTHER

Sponsor Role collaborator

Suzhou Municipal Hospital

OTHER

Sponsor Role collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Changzhou

OTHER

Sponsor Role collaborator

Affiliated Hospital of Jiangsu University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Jingjiang People's Hospital

OTHER

Sponsor Role collaborator

Qingdao Municipal Hospital

OTHER

Sponsor Role collaborator

Xi'an No.3 Hospital

OTHER_GOV

Sponsor Role collaborator

Lianyungang Hospital Affiliated Bengbu Medical College

OTHER

Sponsor Role collaborator

Jinzhou Medical University

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Huadong Hospital

OTHER

Sponsor Role collaborator

No. 102 Hospital of Chinese People's Liberation Army

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Wang

Professor & Deputy Director, Department of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Wang, MD

Role: CONTACT

86-21-52888160

cuiyun wu, master

Role: CONTACT

86-21-52888047

Facility Contacts

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Guoying Cao, MD.

Role: primary

86-21-52888047

Feng-Tao Liu, MD.

Role: backup

86-21-52888163

Jian Wang, MD.

Role: primary

86-21-52888160

Feng-Tao Liu, MD.

Role: backup

86-21-52888163

Other Identifiers

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KY2016-214

Identifier Type: -

Identifier Source: org_study_id

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