UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050349
Receipt number R000057334
Scientific Title Impact of comorbidities on Migraine quality of life:Cross-sectional study using receipt data and questionnaire survey
Date of disclosure of the study information 2023/03/01
Last modified on 2023/09/04 05:42:34

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Impact of comorbidities on Migraine quality of life:Cross-sectional study using receipt data and questionnaire survey

Acronym

Impact of comorbidities on Migraine quality of life

Scientific Title

Impact of comorbidities on Migraine quality of life:Cross-sectional study using receipt data and questionnaire survey

Scientific Title:Acronym

Impact of comorbidities on Migraine quality of life:Cross-sectional study using receipt data and questionnaire survey

Region

Japan


Condition

Condition

Migraine

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between QOL associated with migraines and comorbidities

Basic objectives2

Others

Basic objectives -Others

To investigate the relationship between WPAI associated with migraines and comorbidities

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MS-QOL(Migraine-Specific Quality of Life)

Key secondary outcomes

WPAI(Work Productivity and Activity Impairment)


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

06-6943-7722

Email

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 540-0021

TEL

06-6943-7722

Homepage URL


Email

sanoh@otsuka.jp


Sponsor or person

Institute

Otsuka Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

self-procurement

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

Email

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

674

Results

The results suggest that the factors influencing MS-QOL were cerebrovascular depression for RR and RP, schizophrenia and sleep disorders for EF. The number of comorbidities did not influence MS-QOL by the number of comorbidities.
Factors influencing WPAI were sleep disorders in presenteeism and overall work impairment, and depression in activity impairment. The number of comorbidities did not influence the WPAI in terms of the number of comorbidities.

Results date posted

2023 Year 09 Month 04 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 06 Month 28 Day

Date of IRB

2022 Year 06 Month 29 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 21 Day


Other

Other related information

To investigate the relationship between QOL associated with migraines and comorbidities


Management information

Registered date

2023 Year 02 Month 15 Day

Last modified on

2023 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057334