UMIN-CTR Clinical Trial

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

Healthy workers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Keio University, Faculty of Policy Management

Institute

Department

Personal name

Organization

Keio University, Atrae,Inc, Nittsu System Co.Ltd.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

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

慶應義塾大学

Date of disclosure of the study information

2020

Year

06

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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

2024

Year

03

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

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)

Registered date

2020

Year

06

Month

08

Day

Last modified on

2022

Year

12

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046432