UMIN-CTR Clinical Trial

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
Email	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
Email	tomohisa@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055480