UMIN-CTR Clinical Trial

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
Email	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
Email	abesumie@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046853