UMIN-CTR Clinical Trial

Basic information
Public title	Questionnaire Survey for the Impact of COVID-19 Crisis on Patients with Parkinson's Disease and their Caregivers
Acronym	Questionnaire Survey for the Impact of COVID-19 on Parkinson's Disease
Scientific Title	Questionnaire Survey for the Impact of COVID-19 Crisis on Patients with Parkinson's Disease and their Caregivers
Scientific Title:Acronym	Questionnaire Survey for the Impact of COVID-19 on Parkinson's Disease
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the impact of coronavirus disease 2019 (COVID-19) on the behaviors and symptoms of Parkinson's disease (PD) patients and caregiver's burden.
Basic objectives2	Others
Basic objectives -Others	To assess changes in behaviors and symptoms of PD patients and their caregivers burden under COVID-19 pandemic through questionnaire surveys, and investigate the actual impact of COVID-19 pandemic on PD and the factors that indirectly affect PD symptoms in Japan.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Survey in patients: Pattern of outpatient visit and treatment, lifestyle, PD symptoms before and after COVID-19 pandemic Survey in caregivers: Lifestyle, burden and health status of caregivers before and after COVID-19 pandemic
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects must fulfill all of the following criteria: 1) Patients themselves or patients to be cared who belong to Japan Parkinson's Disease Association 2) Patients or caregivers who agree to participate in the survey and to publish the survey results
Key exclusion criteria	No matching the key inclusion criteria
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Yoshihiko Middle name Last name Furusawa
Organization	Takeda Pharmaceutical Company Limited.
Division name	Japan Medical Office
Zip code	103-8668
Address	1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL	03-3278-2111
Email	yoshihiko.furusawa@takeda.com

Public contact
Name of contact person	1st name Yayoi Middle name Last name Kawata
Organization	Takeda Pharmaceutical Company Limited.
Division name	Japan Medical Office
Zip code	103-8668
Address	1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL	03-3278-2111
Homepage URL
Email	yayoi.kawata@takeda.com

Sponsor
Institute	Takeda Pharmaceutical Company Limited.
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical corporation Takahashi clinic clinical trial examination committee
Address	1-31, Iwayakitamachi, Nada-ku, Kobe-shi, Hyogo
Tel	03-5575-5860
Email	kishimoto.satoshi@neues.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	一般社団法人　全国パーキンソン病友の会/Japan Parkinson’s Disease Association (JPDA)

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 11 Month 18 Day
Date of IRB	2020 Year 11 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2021 Year 02 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study will be conducted as a questionnaire survey of PD patients who belong to JPDA and their caregivers. The questionnaires will be sent to the subjects by mail. The collected completed questionnaires will be anonymized and individuals will not be identified.

Management information
Registered date	2021 Year 01 Month 28 Day
Last modified on	2022 Year 02 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049272