Clinical trial NCT03649503: The National Registry Study for the Real-world Patients with Parkinsonian Disorders in China
Official title: The National Registry Study for the Real-world Patients with Parkinsonian Disorders in China (ForPDCN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinsonian Disorders
Keywords: Brain Health
Brain Research
parkinsonism
prospective cohort study
large sample size
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Tianjin Medical University General Hospital
name: Peking Union Medical College Hospital
name: Chinese PLA General Hospital
name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital of the Fourth Military Medical University
name: Afﬁliated Hospital of North Sichuan Medical College
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Changshu Hospital of Traditional Chinese Medicine
name: The Affiliated Hospital of Qingdao University
name: Guangxi Ruikang Hospital
name: Xi'an Central Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: The First Hospital of Hebei Medical University
name: Jieyang People's Hospital
name: Luoyang Central Hospital
name: Taian City Central Hospital
name: Gansu Provincial Hospital
name: First Affiliated Hospital of Harbin Medical University
name: Daqing Oil Field Hospital
name: Fujian Provincial Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: Taizhou Hospital
name: Zhejiang Hospital
name: The 101st Hospital of Chinese People's Liberation Army
name: The First Affiliated Hospital of Zhengzhou University
name: The First Affiliated Hospital of Dalian Medical University
name: China-Japan Union Hospital, Jilin University
name: Wuhan No.1 Hospital
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Northern Jiangsu People's Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Shanghai 5th People's Hospital
name: Third People's Hospital, Huzhou City, Zhejiang Province, China
name: Suzhou Municipal Hospital
name: Ningbo No. 1 Hospital
name: The First People's Hospital of Changzhou
name: Affiliated Hospital of Jiangsu University
name: The Second Affiliated Hospital of Harbin Medical University
name: The First Affiliated Hospital with Nanjing Medical University
name: Fujian Medical University Union Hospital
name: Shanghai Changzheng Hospital
name: Second Affiliated Hospital of Nanchang University
name: Jingjiang People's Hospital
name: Qingdao Municipal Hospital
name: Xi'an No.3 Hospital
name: Lianyungang Hospital Affiliated Bengbu Medical College
name: The First People's Hospital of Jingzhou
name: Shanghai 10th People's Hospital
name: Huadong Hospital
name: No. 102 Hospital of Chinese People's Liberation Army
name: Shandong Provincial Hospital
name: Anhui Provincial Hospital
name: Affiliated Hospital of Guangdong Medical University
First posted: 2018-08-28
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

Anyone with Parkinsonian Disorders is welcome to join the Registry.

Exclusion Criteria:

Primary outcomes:
measure: Change from Baseline in the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8) Score
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References: