UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041027 |
|---|---|
| Receipt number | R000046853 |
| Scientific Title | A study of changes in human behavior and contact during an infectious disease epidemic |
| Date of disclosure of the study information | 2020/07/07 |
| Last modified on | 2021/01/05 11:17:16 |
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Basic information
Public title
A study of changes in human behavior and contact during an infectious disease epidemic
Acronym
A study of changes in human behavior and contact during an infectious disease epidemic
Scientific Title
A study of changes in human behavior and contact during an infectious disease epidemic
Scientific Title:Acronym
A study of changes in human behavior and contact during an infectious disease epidemic
Region
| Japan |
Condition
Condition
Infectious diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By observing changes in human behavior and frequency of contact with others at multiple points in an infectious disease epidemic, we will determine how social behavioral changes contribute to the prevention of the spread of infectious disease.
Basic objectives2
Others
Basic objectives -Others
Evaluate the association between the actual observed infectious disease outbreaks and the behavioral changes seen in this study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examine which recommendations are effective in preventing infectious diseases by examining changes in behavior related to human-human contact following public health recommendations.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This is for those who reside in Japan.
Key exclusion criteria
No special provision is made.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hirono |
| Middle name | |
| Last name | Otomaru |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8575
Address
2-1, Seiryo, Aoba, Sendai, Miyagi
TEL
022-717-8211
otomaruh@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Sumie |
| Middle name | |
| Last name | Abe |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8575
Address
2-1, Seiryo, Aoba, Sendai, Miyagi
TEL
022-717-8211
Homepage URL
abesumie@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics Committee Tohoku University Hospital
Address
1-1, Seiryo, Aoba, Sendai, Miyagi
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2020 | Year | 07 | Month | 07 | 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
0
Results
Due to the nature of the research, it was necessary to start the study before and after the infectious disease epidemic. However, due to budget-related procedures, we did not recruit any participants.
Results date posted
| 2021 | Year | 01 | Month | 05 | Day |
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
Terminated
Date of protocol fixation
| 2020 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Conduct observations on the relationship between public health recommendations and changes in human behavior.
Management information
Registered date
| 2020 | Year | 07 | Month | 07 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046853
