UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046394 |
|---|---|
| Receipt number | R000052939 |
| Scientific Title | Observational study on the stress check using data from wearable devices, and on the evaluation of the relationships between stress check, work engagement and work productivity |
| Date of disclosure of the study information | 2021/12/16 |
| Last modified on | 2026/01/07 12:05:41 |
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Basic information
Public title
Observational study on the stress check using data from wearable devices, and on the evaluation of the relationships between stress check, work engagement and work productivity
Acronym
Observational study on the stress check using data from wearable devices, and on the evaluation of the relationships between stress check, work engagement and work productivity
Scientific Title
Observational study on the stress check using data from wearable devices, and on the evaluation of the relationships between stress check, work engagement and work productivity
Scientific Title:Acronym
Observational study on the stress check using data from wearable devices, and on the evaluation of the relationships between stress check, work engagement and work productivity
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of the algorism to detect mental illness using data from wearable devices
Basic objectives2
Others
Basic objectives -Others
Development of algorism
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The Brief Job Stress Questionnaire (23 Items)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Employee in Shionogi & Co. Ltd. (including its group companies) who belongs to the below departments and can perform evaluation by application by themselves.
(Pharmaceutical Research Division, Drug Development and Regulatory Science Division, Pharmaceutical Commercial Division in Osaka, Administration Division, Integrated Disease Care Division, DX promotion Division, Shionogi Career Development Center Co., Ltd.,)
*Those who can answer questionnaires via web application.
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshitake |
| Middle name | |
| Last name | Kitanishi |
Organization
Shionogi & Co., Ltd.
Division name
Data Science department
Zip code
5410045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Japan
TEL
06-6202-2161
yoshitake.kitanishi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Yoshida |
Organization
Shionogi & Co., Ltd.
Division name
Data Science department
Zip code
5410045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Japan
TEL
06-6202-2161
Homepage URL
yuuki.yoshida@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
20-9-401, Mita, 5-chome, Minato-ku, Tokyo, Japan.
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://ai.jmir.org/2024/1/e55840
Number of participants that the trial has enrolled
194
Results
Data from 190 participants were analyzed (teleworking rate: 0-79%). The proposed model achieved an AUC of 0.84 (TPR/FPR: 0.77/0.26). SHAP analysis showed that high teleworkers' stress was linked to skipped lunch, irregular work hours, higher heart rate variability, and reduced sleep, whereas low teleworkers' stress was linked to deviations in arrival time, heart rate variability, and calorie expenditure variations.
Results date posted
| 2026 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 02 | Day |
Baseline Characteristics
This study enrolled 194 employees of the Shionogi Group working in Osaka, Japan. Participants who rarely teleworked included sales or research employees, and those who frequently teleworked included clerical employees. The teleworking rate of the employees ranged between 0% and 79%.
Participant flow
Data from 190/194 (97.9%) participants were included to develop high-performance stress prediction algorithms; 2 participants discontinued the study, and data from 2 other participants were included only in the training set.
Adverse events
Not investigated
Outcome measures
The area under the curve (AUC) of the proposed method was 0.84 (true positive vs false positive: 0.77 vs 0.26).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 16 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052939
