UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049805 |
|---|---|
| Receipt number | R000056728 |
| Scientific Title | Health survey for general population during the COVID-19 pandemic |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2022/12/16 14:33:22 |
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Basic information
Public title
Health survey for general population during the COVID-19 pandemic
Acronym
Health survey for general population during the COVID-19 pandemic
Scientific Title
Health survey for general population during the COVID-19 pandemic
Scientific Title:Acronym
Health survey for general population during the COVID-19 pandemic
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the presence of long-term symptoms after COVID-19, physical and mental health, and socioeconomic status of patients with COVID-19 and age- and sex-matched non-infected residents
Basic objectives2
Others
Basic objectives -Others
Presence of long-term symptoms after COVID-19, physical and mental health, and socioeconomic status
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of long-term symptoms after COVID-19 and new onset diseases
Key secondary outcomes
Physical and mental health, socioeconomic status, lifestyles, and status of taking medical care
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Adults aged between 20 and 69* who live in Shinagawa city and were diagnosed with COVID-19 and registered in HER-SYS in July and August 2022 (COVID-19 group) and age- and sex-matched non-infected residents* (Control group)
2) Those who have consented to participate in this study
* age at the time of participant selection
** We excluded those who were registered in HER-SYS between January 2020 and the time of participant selection.
Key exclusion criteria
(1) Persons deemed unfit by the principal investigator and the research collaborators
(e.g., those who have moved out of the city or died at the time of participant selection)
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iso |
Organization
National Center for Global Health and Medicine
Division name
Institute for Global health Policy Research, Bureau of International Health Cooperation
Zip code
162-8655
Address
1-21-1, Toyama Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
hiso@it.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Hosozawa |
Organization
National Center for Global Health and Medicine
Division name
Institute for Global health Policy Research, Bureau of International Health Cooperation
Zip code
162-8655
Address
1-21-1, Toyama Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
mhosozawa@it.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, National Center for Global Health and Medicine
Address
1-21-1, Toyama Shinjuku-ku, Tokyo, Japan
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional study of patients who live in Shinagawa city, Tokyo, and were diagnosed with COVID-19 during July and August 2022, and age-, sex-matched non-infected residents. A self-administered questionnaire will be used to examine long-term symptoms associated with COVID-19, new onset diseases, physical and mental health status, and socioeconomic status.
Management information
Registered date
| 2022 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056728
| 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 |
