UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036231 |
|---|---|
| Receipt number | R000041275 |
| Scientific Title | Development of a model for supporting a health and productivity management of small and medium-sized companies using IoT and AI contributing to the mental and physical health improvement of employees: A Mixed Method |
| Date of disclosure of the study information | 2019/03/18 |
| Last modified on | 2022/12/21 15:16:05 |
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Basic information
Public title
Development of a model for supporting a health and productivity management of small and medium-sized companies using IoT and AI contributing to the mental and physical health improvement of employees
Acronym
Development of a model for supporting a health and productivity management of small and medium-sized companies using IoT
Scientific Title
Development of a model for supporting a health and productivity management of small and medium-sized companies using IoT and AI contributing to the mental and physical health improvement of employees: A Mixed Method
Scientific Title:Acronym
Development of a model for supporting a health and productivity management of small and medium-sized companies using IoT: A Mixed Method
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of the health and productivity management of companies that have implemented the health and productivity management program including the IoT-based behavior change program for improving the health of employees. Finally, we will evaluate the model to support the health and productivity management of small and medium-sized companies.
Basic objectives2
Others
Basic objectives -Others
Qualitative and quantitative evaluation of the model
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
As it is an exploratory study of evaluating the model, multiple evaluation items are set.
1. Psychological Indicators: Work engagement (UWES: Utrecht Work Engagement Scale) score, Job and family satisfaction (work stress questionnaire)
2. Labor Productivity: Presentism / absentism (WHO-HPQ, short version) score
3. Sleep improvement: Pittsburgh Sleep Quality Index (PSQI)
4. Health literacy: HLS-EU-Q47 Japanese version, Degree of interest one's own body: Likert scale (0 to 10)
5. Behavior change indicators: Frequency rate of using IoT and changes in values
6. Physiological Indicators (collected by IoT): blood pressure, body weight
7. Qualitative evaluation of this model: Interviews and observation: progress of the health and productivity management, evaluation of this model, attainment rate of health-checkup, improvement of health checkup results/number of medical treatment needy/who made a hospital visits/without hospital visits employees
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All employees (included Regular and part-time employment, all types of work-style) from small and medium-sized companies (ACT CHUSHOKU, Co. LTD., Miyoshi Kamotsu Express (ended in July 2020), FRESTA, Co., LTD., TSUBAME Travel Co., LTD), and who did not opt-out in this study.
Key exclusion criteria
1 Those who requested opt-out in this study
2 Part-time job students
3 Those who are absent for more than 3 months in the study site for any reason
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Moriyama |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
Kasumi 1-2-3, Minamiku, Hiroshima
TEL
082-257-5365
morimich@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Moriyama |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
Kasumi 1-2-3, Minamiku, Hiroshima
TEL
082-257-5365
Homepage URL
morimich@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
Tel
082-257-1576
iryo-seisaku@office.hiroshima-u.ac.jp
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
| 2019 | Year | 03 | Month | 18 | 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
401
Results
Due to COVID-19, it was difficult to work with the company, and they were forced to significantly reduce sales and suspend business. As a result, no significant improvement was observed, but as a result of each company's efforts, and efforts to maintain the physical and mental health of employees, the baseline condition was maintained.
Results date posted
| 2022 | Year | 06 | Month | 23 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Currently under review process of a journal (baseline data), and now producing a manuscript on this cohort study.
Date of the first journal publication of results
Baseline Characteristics
A total of 760 employees enrolled, among them 439 retuned. Validated answers were 377, which were analyzed for this study.
The characteristics of the employees were shown in Table 1. More males (60.5%), and the highest percentage of age group was in the 40s(27.6%) following 50s(26.5%). The majority (70.3%) were married, and regarding work years, 10 to 15 years were the most (21.8%). Physical activity levels were low (Level 1) 17.0%, normal (Level 2) 45.1%, and high (Level 3) 33.4%. Regarding the quality of sleep and HL, 39.0% have sleep disorders with a score of 6 or higher on PIQS, and 72.4% showed low HL with a score of 33 or lower on HLS-EL-Q47.
Participant flow
Enveloped questionnaires were distributed to the employees on an opt-out basis through the personnel manager of each company who was assigned a health and productivity manager position in this study. After participants filled the questionnaires, they returned the questionnaire in a sealed envelope through in-house mail.
Adverse events
None
Outcome measures
Work engagement, presenteeism, concern on own body, job satisfaction, family life satisfaction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Companies who participated in this project implement a health and productivity management program including health behavior change programs with supporters outside of the companies (for 1.5 years) (Observational research).
Management information
Registered date
| 2019 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041275
