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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041073
Receipt No. 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 2020/07/12

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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
Email 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
Email ichirosekine@yahoo.co.jp

Sponsor
Institute Shonan Kamakura General Hospital
Institute
Department

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
Email 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 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 Open public recruiting
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 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 07 Month 12 Day
Last modified on
2020 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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