UMIN-CTR Clinical Trial

Basic information
Public title	Longitudinal study on work style change, health and well-being due to pandemic of novel coronavirus infection (COVID-19)
Acronym	Study on COVID-19 and worker well-being
Scientific Title	Longitudinal study on work style change, health and well-being due to pandemic of novel coronavirus infection (COVID-19)
Scientific Title:Acronym	Study on COVID-19 and worker well-being
Region	Japan

Condition
Condition	Healthy workers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the longitudinal relationship between work style changes due to COVID-19 pandemic on one hand and health and well-being of workers on the other hand.
Basic objectives2	Others
Basic objectives -Others	Two longitudinal questionnaire surveys are conducted for employees working at companies.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Stress responses, Mental health, Work engagement, Job performance, Subjective health
Key secondary outcomes	Work style change, Occupational stress, Life style, Coping, Recovery experience, Social network, Work-life balance, Work-life balance self-efficacy, Natural environment, Pet attachment

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
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	Employee (Regular employee/staff)
Key exclusion criteria	Self-employed, Freelance work, Part-time staff
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Akihito Middle name Last name Shimazu
Organization	Keio University
Division name	Faculty of Policy Management
Zip code	252-0882
Address	5322 Endo, Fujisawa-shi
TEL	0466-49-3638
Email	ashimazu-tky@umin.ac.jp

Public contact
Name of contact person	1st name Masahito Middle name Last name Tokita
Organization	Keio University
Division name	Graduate School of Media and Governance
Zip code	252-0882
Address	5322 Endo, Fujisawa-shi
TEL	0466-48-3165
Homepage URL
Email	tokitam-tky@umin.ac.jp

Sponsor
Institute	Keio University, Faculty of Policy Management
Institute
Department

Funding Source
Organization	Keio University, Atrae,Inc, Nittsu System Co.Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee, SFC, Keio University, Japan
Address	5322 Endo, Fujisawa-city, Kanagawa, Japan
Tel	0466-49-3418
Email	somu@sfc.keio.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	20E0004
Org. issuing International ID_1	Public Health Research Foundation
Study ID_2	336
Org. issuing International ID_2	Research Ethics Committee, SFC, Keio University, Japan
IND to MHLW

Institutions
Institutions	慶應義塾大学

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 08 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
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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	Enrolling by invitation
Date of protocol fixation	2020 Year 05 Month 22 Day
Date of IRB	2020 Year 05 Month 22 Day
Anticipated trial start date	2020 Year 06 Month 08 Day
Last follow-up date	2022 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1. JFMA study Prospective design. Two-wave questionnaire surveys with three months interval. 2. Internet study Prospective design. Four-wave questionnaire surveys with three months interval. To examine the relationship between work style changes due to COVID-19 pandemic on one hand and health and well-being on the other hand. <edit 1> 1. JFMA survey has been terminated; 2. Internet survey was originally planned to be conducted every three months starting in June 2020, with three follow-up surveys in September, December and March 2021; however, in consideration of the situation during COVID-19 pademic, four follow-up surveys will be conducted every three months starting in June 2021,and following surveys in September, December and March 2022. Ethical Review Approved by the Keio University SFC Research Ethics Committee (Approval number: 336, Application date: 12 April 2021, Approved date: 21 April 2021)

Management information
Registered date	2020 Year 06 Month 08 Day
Last modified on	2021 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046432

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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