UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048692 |
|---|---|
| Receipt number | R000055480 |
| Scientific Title | The effects of fatigue measurement and advice on how to improve lifestyle on reducing of fatigue and work-related errors: A randomized controlled trial |
| Date of disclosure of the study information | 2022/08/18 |
| Last modified on | 2022/08/18 15:38:12 |
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Basic information
Public title
The effects of fatigue measurement and advice on how to improve lifestyle on reducing of fatigue and work-related errors: A randomized controlled trial
Acronym
The effects of fatigue measurement and advice on how to improve lifestyle on reducing of fatigue and work-related errors
Scientific Title
The effects of fatigue measurement and advice on how to improve lifestyle on reducing of fatigue and work-related errors: A randomized controlled trial
Scientific Title:Acronym
The effects of fatigue measurement and advice on how to improve lifestyle on reducing of fatigue and work-related errors
Region
| Japan |
Condition
Condition
fatigue
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify whether an intervention by measuring fatigue and providing lifestyle advice via smartphones can improve fatigue and reduce work-related errors (near-misses).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue(Chalder Fatigue Scale, Visual Analog Scale)(three months later)
Key secondary outcomes
Number of near-misses
Sleep(the Pittsburgh. Sleep Quality Index)
Presenteeism: WPAI(Work Productivity and Activity Impairment Questionnaire)
Perceived organizational support
(all measurements three months later)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Measuring fatigue levels
The autonomic nervous system is measured quantitatively from the pulse of the fingertip using the camera function of the smartphone (measurement frequency is once a day and every day). The results are also viewed by the individual on his/her smartphone.
Interventions/Control_2
Personalized self-care application provides advice for lifestyle improvement. Based on the results of fatigue measurements, advice on necessary lifestyle habits and actions will be delivered via smartphone. The advice can be delivered up to three times a day, and each message can be read in a few minutes.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Workers in the information and communication industry
Key exclusion criteria
Those with a BMI of 30 or more or a BMI of less than 17.0
Pregnant or lactating mothers
Have a history of heart surgery or are currently undergoing treatment for heart disease
Those who have high blood pressure and are taking antihypertensive medication(beta blockers)
Persons under treatment for mental illness
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Nagata |
Organization
University of Occupational and Environmental Health, Japan
Division name
Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
TEL
+81-93-603-1611
tomohisa@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Nagata |
Organization
University of Occupational and Environmental Health, Japan
Division name
Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
TEL
+81-93-603-1611
Homepage URL
tomohisa@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
This study was funded by the research grant from TIS Inc.
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
University of Occupational and Environmental Health, Japan
Address
1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
Tel
+81-93-603-1611
tomohisa@med.uoeh-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
TISシステムサービス株式会社（東京都、愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | 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
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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 18 | Day |
Last modified on
| 2022 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055480
