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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040683
Receipt No. R000046432
Scientific Title Longitudinal study on work style change, health and well-being due to pandemic of novel coronavirus infection (COVID-19)
Date of disclosure of the study information 2020/06/08
Last modified on 2021/05/14

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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
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
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
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 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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