UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040683 |
|---|---|
| Receipt number | 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 | 2024/06/11 22:15:59 |
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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
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
https://hp3.jp/project/study-on-covid-19-and-worker-well-being
tokitam-tky@umin.ac.jp
Sponsor or person
Institute
Keio University, Faculty of Policy Management
Institute
Department
Personal name
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
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
| 2025 | Year | 03 | Month | 31 | 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 a three months interval.
2. Internet study
Prospective design. Four-wave questionnaire surveys with three months intervals.
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 pandemic, four follow-up surveys will be conducted every three months starting in June 2021, and following surveys in September, December and March 2022.
<edit 2>
As for the Internet survey, considering the social situation caused by the COVID-19 pandemic, we decided to continue the follow-up survey after June 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
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046432
