UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052733 |
|---|---|
| Receipt number | R000060083 |
| Scientific Title | Study of Work Productivity by Disease Using a health insurance association in Japan |
| Date of disclosure of the study information | 2023/11/08 |
| Last modified on | 2023/11/08 17:06:22 |
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Basic information
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
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
Objectives
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
Assessment
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
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
| 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
Research contact person
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
Yamato.Kentaro@otsuka.jp
Public contact
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
Yamato.Kentaro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Otsuka Pharmaceutical Co.,Ltd. Research Department Research Ethics Committee
Address
10-463 Kagasuno Kawachi cho Tokushima city Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
| 2023 | Year | 11 | Month | 08 | 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
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
Progress
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
Other related information
Calculating Abcentism, Presentism Based on Duration Prevalence and WPAI by Disease-Classification
Management information
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/ctr_e/ctr_view.cgi?recptno=R000060083
