UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041073 |
|---|---|
| Receipt number | R000046864 |
| Scientific Title | A study of changes in emergency department patient dynamics during the COVID-19 outbreak |
| Date of disclosure of the study information | 2020/07/12 |
| Last modified on | 2021/06/26 12:48:20 |
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Basic information
Public title
A study of changes in emergency department patient dynamics during the COVID-19 outbreak
Acronym
COVID-19 Outbreak in Emergency Department
Scientific Title
A study of changes in emergency department patient dynamics during the COVID-19 outbreak
Scientific Title:Acronym
COVID-19 Outbreak in Emergency Department
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of non-pharmaceutical interventions to prevent the spread of novel coronavirus infections in Japan on emergency care.
Basic objectives2
Others
Basic objectives -Others
To determine the impact of the novel coronavirus infection on the dynamics of patients seen in our hospital's emergency department.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the number of patients seen in the year of the new coronavirus outbreak and the average number of patients seen over a five-year period
Key secondary outcomes
Incidence of new coronavirus infection in the year of the new coronavirus outbreak.
Comparison of the yearly incidence of novel coronavirus infection and the proportion of emergency cases seen by average patients over a five-year period.
Comparison between the year of the new coronavirus outbreak and the average number of patients seen over a five-year period.
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
Patients in the emergency room
Key exclusion criteria
none
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamagami |
Organization
Shonan Kamakura General Hospital
Division name
Department of Emergency Medicine
Zip code
2470072
Address
1370-1 Okamoto, Kamakura city, Kanagawa
TEL
+81-467-46-1717
defender8chan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Sekine |
Organization
Shonan Kamakura General Hospital
Division name
Department of Emergency Medicine
Zip code
2470072
Address
1370-1 Okamoto, Kamakura city, Kanagawa
TEL
+81-467-46-1717
Homepage URL
ichirosekine@yahoo.co.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
none
Address
none
Tel
none
none
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
| 2020 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/ams2.603
Number of participants that the trial has enrolled
109429
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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 07 | Month | 12 | Day |
Last modified on
| 2021 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046864
| 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 |
