UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050351 |
|---|---|
| Receipt number | R000057338 |
| Scientific Title | A study on the relationship between the number of headaches, quality of life, and labor productivity (Cross-sectional study using receipt data and questionnaire survey results) |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/08/16 11:11:42 |
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Basic information
Public title
A study on the relationship between the number of headaches, quality of life, and labor productivity
(Cross-sectional study using receipt data and questionnaire survey results)
Acronym
A study on the relationship between the number of headaches, quality of life, and labor productivity
Scientific Title
A study on the relationship between the number of headaches, quality of life, and labor productivity
(Cross-sectional study using receipt data and questionnaire survey results)
Scientific Title:Acronym
A study on the relationship between the number of headaches, quality of life, and labor productivity
(Cross-sectional study using receipt data and questionnaire survey results)
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to investigate the relationship between MHD and QOL and WPAI.
Basic objectives2
Others
Basic objectives -Others
To investigate the threshold from MHD to CM, analyses will be performed by stratifying into MHD categories, and categories where there are differences in MQ-QOL will be investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MS-QOL(Migraine-Specific Quality of Life)
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
| 19 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Health insurance union members (approximately 600,000) who have agreed to secondary use of medical data contracted by DeSC, who are 19 to 75 years old, and who are health promotion support service app kencom provided by DeSC for health insurance unions 150,000 registrants (about 150,000) were assessed as having migraine (including suspected migraine) based on the ICHD-3 questionnaire. group
Key exclusion criteria
none
Target sample size
691
Research contact person
Name of lead principal investigator
| 1st name | hiromi |
| Middle name | |
| Last name | sano |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27 Ote-dori,Chuo-ku,Osaka 540-0021
TEL
0669437722
sanoh@otsuka.jp
Public contact
Name of contact person
| 1st name | hiromi |
| Middle name | |
| Last name | sano |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27 Ote-dori,Chuo-ku,Osaka
TEL
0669437722
Homepage URL
sanoh@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
self-financing
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
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
0886652126
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 | 03 | Month | 01 | 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
671
Results
The target population was a health insurance association, and approximately 90% of the participants were workers.
There was a weak correlation between MHD and MS-QOL.
MHD and Absenteeism did not differ by headache day category.
WPAI (except Absenteeism) differed between MHD (0-7 days) and MHD (8 or more days).
There was a difference in MS-QOL between MHD (0-14 days) and MHD (15 days or more).
MHD (0-3 days) also had lower MS-QOL and greater WPAI.
Results date posted
| 2023 | Year | 08 | Month | 16 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 04 | Month | 05 | Day |
Other
Other related information
The objective is to investigate the relationship between MHD and QOL and WPAI.
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057338
