UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043167 |
|---|---|
| Receipt number | R000049272 |
| Scientific Title | Questionnaire Survey for the Impact of COVID-19 Crisis on Patients with Parkinson's Disease and their Caregivers |
| Date of disclosure of the study information | 2021/01/29 |
| Last modified on | 2022/02/07 10:15:54 |
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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
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
yayoi.kawata@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049272
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
