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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649503
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Tianjin Medical University General Hospital
Peking Union Medical College Hospital
Chinese PLA General Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of the Fourth Military Medical University
Affiliated Hospital of North Sichuan Medical College
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Changshu Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Qingdao University
Guangxi Ruikang Hospital
Xi'an Central Hospital
First Affiliated Hospital of Chongqing Medical University
The First Hospital of Hebei Medical University
Jieyang People's Hospital
Luoyang Central Hospital
Taian City Central Hospital
Gansu Provincial Hospital
First Affiliated Hospital of Harbin Medical University
Daqing Oil Field Hospital
Fujian Provincial Hospital
The Affiliated Hospital of Xuzhou Medical University
Taizhou Hospital
Zhejiang Hospital
The 101st Hospital of Chinese People's Liberation Army
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Dalian Medical University
China-Japan Union Hospital, Jilin University
Wuhan No.1 Hospital
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Northern Jiangsu Province People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai 5th People's Hospital
Third People's Hospital, Huzhou City, Zhejiang Province, China
Suzhou Municipal Hospital
Ningbo No. 1 Hospital
The First People's Hospital of Changzhou
Affiliated Hospital of Jiangsu University
The Second Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital with Nanjing Medical University
Fujian Medical University Union Hospital
Shanghai Changzheng Hospital
Second Affiliated Hospital of Nanchang University
Jingjiang People's Hospital
Qingdao Municipal Hospital
Xi'an No.3 Hospital
Lianyungang Hospital Affiliated Bengbu Medical College
The First People's Hospital of Jingzhou
Shanghai 10th People's Hospital
Huadong Hospital
No. 102 Hospital of Chinese People's Liberation Army
Shandong Provincial Hospital
Anhui Provincial Hospital
The Affiliated Hospital of Guangdong Medical College
Information provided by (Responsible Party):
Jian Wang, Huashan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Parkinsonian Disorders 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The National Registry Study For the Real-world Patients With Parkinsonian Disorders in China (ForPDCN)
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2028
Estimated Study Completion Date : September 30, 2033

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change from Baseline in the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8) Score [ Time Frame: 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) ]

    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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

Anyone with Parkinsonian Disorders is welcome to join the Registry.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649503


Contacts
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Contact: Jian Wang, MD 86-21-52888160 wangjian336@hotmail.com, Wangjian_hs@fudan.edu.cn
Contact: cuiyun wu, master 86-21-52888047 wucuiyun@fudan.edu.cn

Locations
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China, Shanghai
Huashan Hospital Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Guoying Cao, MD.    86-21-52888047    sherley_76@yahoo.com.cn   
Contact: Feng-Tao Liu, MD.    86-21-52888163    liufengtao@fudan.edu.cn   
Principal Investigator: Jian Wang, M.D         
Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Jian Wang, MD.    86-21-52888160    wangjian336@hotmail.com   
Contact: Feng-Tao Liu, MD.    86-21-52888163    liufengtao@fudan.edu.cn   
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.         
Sponsors and Collaborators
Huashan Hospital
First Affiliated Hospital, Sun Yat-Sen University
Tianjin Medical University General Hospital
Peking Union Medical College Hospital
Chinese PLA General Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of the Fourth Military Medical University
Affiliated Hospital of North Sichuan Medical College
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Changshu Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Qingdao University
Guangxi Ruikang Hospital
Xi'an Central Hospital
First Affiliated Hospital of Chongqing Medical University
The First Hospital of Hebei Medical University
Jieyang People's Hospital
Luoyang Central Hospital
Taian City Central Hospital
Gansu Provincial Hospital
First Affiliated Hospital of Harbin Medical University
Daqing Oil Field Hospital
Fujian Provincial Hospital
The Affiliated Hospital of Xuzhou Medical University
Taizhou Hospital
Zhejiang Hospital
The 101st Hospital of Chinese People's Liberation Army
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Dalian Medical University
China-Japan Union Hospital, Jilin University
Wuhan No.1 Hospital
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Northern Jiangsu Province People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai 5th People's Hospital
Third People's Hospital, Huzhou City, Zhejiang Province, China
Suzhou Municipal Hospital
Ningbo No. 1 Hospital
The First People's Hospital of Changzhou
Affiliated Hospital of Jiangsu University
The Second Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital with Nanjing Medical University
Fujian Medical University Union Hospital
Shanghai Changzheng Hospital
Second Affiliated Hospital of Nanchang University
Jingjiang People's Hospital
Qingdao Municipal Hospital
Xi'an No.3 Hospital
Lianyungang Hospital Affiliated Bengbu Medical College
The First People's Hospital of Jingzhou
Shanghai 10th People's Hospital
Huadong Hospital
No. 102 Hospital of Chinese People's Liberation Army
Shandong Provincial Hospital
Anhui Provincial Hospital
The Affiliated Hospital of Guangdong Medical College

Additional Information:

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Responsible Party: Jian Wang, Professor & Deputy Director, Department of Neurology, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03649503    
Other Study ID Numbers: KY2016-214
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Jian Wang, Huashan Hospital:
Brain Health
Brain Research
parkinsonism
prospective cohort study
large sample size
Additional relevant MeSH terms:
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Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders