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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinsonian Disorders
• Intervention / Treatment: Other: No intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

• Study Contact: Name: cuiyun wu, master; Phone Number: 86-21-52888047; Email: wucuiyun@fudan.edu.cn
• Study Contact Backup: Name: Jian Wang, MD; Phone Number: 86-21-52888160; Email: wangjian336@hotmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Huashan Hospital Affiliated to Fudan University
      • Contact: Guoying Cao, MD.; Phone Number: 86-21-52888047; Email: sherley_76@yahoo.com.cn
      • Contact: Feng-Tao Liu, MD.; Phone Number: 86-21-52888163; Email: liufengtao@fudan.edu.cn
      • Principal Investigator: Jian Wang, M.D
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Huashan Hospital
      • Contact: Feng-Tao Liu, MD.; Phone Number: 86-21-52888163; Email: liufengtao@fudan.edu.cn
      • Contact: Jian Wang, MD.; Phone Number: 86-21-52888160; Email: wangjian336@hotmail.com
      • Principal Investigator: Jian Wang, MD.
      • Sub-Investigator: Zheng-Tong Ding, MD.
      • Sub-Investigator: Jian-Jun Wu, MD.
      • Sub-Investigator: Jian-Feng Luo, PhD
      • Sub-Investigator: Chuan-Tao Zuo, MD.
      • Sub-Investigator: Huan Yu, MD.
      • Sub-Investigator: Yi-Min Sun, PhD
      • Sub-Investigator: Feng-Tao Liu, MD.
      • Sub-Investigator: Su-Shan Luo, MD.
      • Sub-Investigator: Jue Zhao, MD.
      • Sub-Investigator: Yi-Lin Tang, MD.
      • Sub-Investigator: Xiao-Niu Liang, MPH.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The Registry is a large, online database of volunteers who would like to participate in the research. Anyone with Parkinsonian Disorders is welcome to join the Registry.

Description

Inclusion Criteria:

Anyone with Parkinsonian Disorders is welcome to join the Registry.

Exclusion Criteria:

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8) Score	The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients. It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all). The total scores range from 0 (good health) to 32 (poor health). The change of PDQ-8 score is defined as the score collected at visit 4 (end of year 1), visit 8 (end of year 2), visit 12 (end of year 3), visit 16 (end of year 4), visit 20 (end of year 5), visit 24 (end of year 6), visit 28 (end of year 7), visit 32 (end of year 8), visit 36 (end of year 9), visit 40 (end of year 10), and final visit (last study visit or early withdrawal visit, up to 10 years) minus baseline score. Analysis Method: Mixed Model Repeated Measures (MMRM)	Baseline, year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and final visit (last study visit or early withdrawal visit, up to 10 years)

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Xi'an Central Hospital; Peking Union Medical College Hospital; Shanghai Zhongshan Hospital; Chinese PLA General Hospital; First Affiliated Hospital, Sun Yat-Sen University; The Affiliated Hospital of Qingdao University; Shanghai 10th People's Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Shandong Provincial Hospital; The First Affiliated Hospital of Zhengzhou University; Qingdao Municipal Hospital; Gansu Provincial Hospital; Tianjin Medical University General Hospital; Fujian Medical University Union Hospital; The Second Affiliated Hospital of Harbin Medical University; Shanghai Changzheng Hospital; The First Hospital of Hebei Medical University; Ningbo No. 1 Hospital; Shanghai Tongji Hospital, Tongji University School of Medicine; Second Affiliated Hospital of Nanchang University; First Affiliated Hospital of Chongqing Medical University; Affiliated Hospital of Jiangsu University; The Affiliated Hospital of Xuzhou Medical University; Fujian Provincial Hospital; The First Affiliated Hospital of the Fourth Military Medical University; Taizhou Hospital; China-Japan Union Hospital, Jilin University; The First Affiliated Hospital of Dalian Medical University; First Affiliated Hospital of Harbin Medical University; Anhui Provincial Hospital; Shanghai Jiao Tong University Affiliated Sixth People's Hospital; Wuhan No.1 Hospital; Jieyang People's Hospital; Suzhou Municipal Hospital; The First People's Hospital of Changzhou; Luoyang Central Hospital; Xi'an No.3 Hospital; Taian City Central Hospital; Affiliated Hospital of North Sichuan Medical College; Guangxi Ruikang Hospital; Huadong Hospital; Shanghai 5th People's Hospital; Jingjiang People's Hospital; Daqing Oil Field Hospital; Lianyungang Hospital Affiliated Bengbu Medical College; Zhejiang Hospital; Changshu Hospital of Traditional Chinese Medicine; The 101st Hospital of Chinese People's Liberation Army; Third People's Hospital, Huzhou City, Zhejiang Province, China; No. 102 Hospital of Chinese People's Liberation Army; Affiliated Hospital of Guangdong Medical University; Northern Jiangsu People's Hospital; Jinzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2033

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 26, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: parkinsonism; Brain Health; Brain Research; prospective cohort study; large sample size
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Basal Ganglia Diseases; Parkinsonian Disorders
• Other Study ID Numbers: KY2016-214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No