![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 | 2020/12/08 |
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 |
|
Condition | ||
Condition | Healthy workers | |
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |||||||
sfujihara@keio.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 | Public Health Research Foundation |
Address | 1-1-7 Nishi-Waseda, Shinjuku-Ku |
Tel | 03-5287-5070 |
rinri@phrf.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | 20E0004 |
Org. issuing International ID_1 | Public Health Research Foundation |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 慶應義塾大学 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
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. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |