UMIN-ICDS Clinical Trial

Public title

Study of Work Productivity by Disease Using a health insurance association in Japan

Acronym

Study of Work Productivity by Disease Using a health insurance association in Japan

Scientific Title

Study of Work Productivity by Disease Using a health insurance association in Japan

Scientific Title:Acronym

Study of Work Productivity by Disease Using a health insurance association in Japan

Region

Japan

Condition

all diseases

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Cardiology	Pneumology	Endocrinology and Metabolism
Hematology and clinical oncology	Nephrology	Neurology
Clinical immunology	Psychosomatic Internal Medicine	Infectious disease
Geriatrics	Surgery in general	Gastrointestinal surgery
Hepato-biliary-pancreatic surgery	Vascular surgery	Chest surgery
Endocrine surgery	Breast surgery	Obstetrics and Gynecology
Ophthalmology	Dermatology	Psychiatry
Oto-rhino-laryngology	Orthopedics	Urology
Oral surgery	Neurosurgery	Cardiovascular surgery
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Calculating Abcentism, Presentism Based on Duration Prevalence and WPAI by Disease-Classification
Calculating the amount of work loss by disease classification by sex, age, and job

Basic objectives2

Others

Basic objectives -Others

N/A

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

WPAI (Absenteeism Presenteeism Total work productivity impairment Total activity impairment)

Key secondary outcomes

the amount of work loss by disease classification by sex, age, and job

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

19

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1 Persons who agreed to use the secondary data
2 Persons who have registered for kencom app and meet the following criteria
Persons who responded in June 2021 or December 2021.
Persons who were 19 years or older at June and December 2021 questionnaire data were collected.
Persons who answered 'yes' to Q1 of WPAI questionnaire and were confirmed to be employed at the time the June and December 2021 survey data were collected.
Persons who answered 'yes' to Q2-Q6 of WPAI questionnaire at the time of data collection in either June or December 2021.

WPAI Questionnaire
Q1 Are you currently employed? Do you have a remunerated job?
Q2 In the past 7 days, how many hours did you miss from work due to health problems? Please include all the hours you missed because of health problems and all the hours you were late or left early. Do not include time off to participate in this survey.
Q3 In the past 7 days, how many hours did you take off from work for reasons other than health problems, such as holidays and time off to participate in this survey?
Q4 How many hours did you actually work during the past 7 days?
Q5 How much did your health problems affect your productivity while you were working in the past 7 days?
Q6 How much did your health problems affect your daily activities outside of work during the past 7 days?

Key exclusion criteria

Persons who answered "12. student" or "13. unemployed" in Q4 of the questionnaire on job category.

(Occupation Questionnaire)
Q4. What is your type of occupation?
(Choice)
1. professional/technical (doctor, nurse, lawyer, engineer, designer, management consultant, interpreter, editor, etc.)
2. managerial position (managerial positions at the section chief level or above, manager or executive of a company or organization, etc.)
3. clerical work (accounting clerks, sales clerks, receptionists, secretaries, investigators, etc.)
4. sales staff
5. sales jobs
6. transportation and communication occupations (truck and cab drivers, seamen, mail carriers, etc.)
Security occupations (police officers, firefighters, self-defense guards, security guards, etc.)
8. skilled and labor occupations (auto mechanics, construction workers, electricians, etc.)
Agriculture, forestry, and fisheries (crop production, livestock rearing, etc.)
10. service occupations (qualifications required) (hairdressers, care workers, cooks, etc.)
11. service occupations (no qualifications required)
12. student
13. unemployed
14. other

Target sample size

30000

Name of lead principal investigator

1st name	Kentaro
Middle name
Last name	Yamato

Organization

Otsuka Pharmaceutical Co.,Ltd.

Division name

Medical Affairs

Zip code

108-8241

Address

Shinagawa Grand Central Tower 2-16-4 Konan,Minato-ku, Tokyo 108-8242, Japan

TEL

03-6717-1400

Email

Yamato.Kentaro@otsuka.jp

Name of contact person

1st name	Kentaro
Middle name
Last name	Yamato

Organization

Otsuka Pharmaceutical Co.,Ltd.

Division name

Medical Affairs

Zip code

108-8241

Address

Shinagawa Grand Central Tower 2-16-4 Konan,Minato-ku, Tokyo 108-8242, Japan

TEL

03-6717-1400

Homepage URL

Email

Yamato.Kentaro@otsuka.jp

Institute

Otsuka Pharmaceutical Co.,Ltd.

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Otsuka Pharmaceutical Co.,Ltd. Research Department Research Ethics Committee

Address

10-463 Kagasuno Kawachi cho Tokushima city Tokushima

Tel

088-665-2126

Email

Suzuki.Takashi@otsuka.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

30000

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

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

10

Month

17

Day

Date of IRB

2023

Year

10

Month

12

Day

Anticipated trial start date

2023

Year

11

Month

15

Day

Last follow-up date

2023

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Calculating Abcentism, Presentism Based on Duration Prevalence and WPAI by Disease-Classification

Registered date

2023

Year

11

Month

08

Day

Last modified on

2023

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060083