UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048480 |
|---|---|
| Receipt number | R000054839 |
| Scientific Title | Survey on post COVID-19 health condition one year after discharge |
| Date of disclosure of the study information | 2022/07/27 |
| Last modified on | 2023/08/21 19:07:23 |
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Basic information
Public title
Survey on post COVID-19 health condition one year after discharge
Acronym
Survey on post COVID-19 health condition one year after discharge
Scientific Title
Survey on post COVID-19 health condition one year after discharge
Scientific Title:Acronym
Survey on post COVID-19 health condition one year after discharge
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since the long-term health condition after COVID-19 is not yet known, we decided to conduct a questionnaire survey on the health status one year after discharge from COVID-19.
Basic objectives2
Others
Basic objectives -Others
Changes including socioeconomic background after COVID-19 disease
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Post-COVID condition 1 year after discharge
Key secondary outcomes
Changes in patient background, including socioeconomic status
HADS score, Pittsburgh Sleep Questionnaire,SF-8
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have registered for the "Survey on COVID-19 sequelae (for patients with moderate disease or higher)" led by the Japanese Respiratory Society.
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Yokoyama |
Organization
Kochi Medical school, Kochi University
Division name
Department of Respiratory and Allergy Medicine
Zip code
783-8505
Address
Oko-cho, Kohasu, Nankoku, Kochi
TEL
0888802345
ayokoyama@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazufumii |
| Middle name | |
| Last name | Takamatsu |
Organization
Kochi Medical school, Kochi University
Division name
Department of Respiratory and Allergy Medicine
Zip code
783-8505
Address
Oko-cho, Kohasu, Nankoku, Kochi
TEL
0888802345
Homepage URL
ktakamatsu@kochi-u.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor 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
Kochi University ethic comittee
Address
Oko-cho, Kohasu, Nankoku, Kochi
Tel
088-866-5811
rinri21@kochi-u.ac.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 | 07 | Month | 27 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
After IRB approval of the research core facility, a survey is planned to start at cooperating facilities in nationwide.
Management information
Registered date
| 2022 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054839
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
