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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035700
Receipt No. R000040667
Scientific Title A study of promoting job and study support for patients of rheumatoid arthritis and their parents
Date of disclosure of the study information 2019/02/01
Last modified on 2019/07/30

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Basic information
Public title A study of promoting job and study support for patients of rheumatoid arthritis and their parents
Acronym A study of promoting job and study support for patients of rheumatoid arthritis and their parents
Scientific Title A study of promoting job and study support for patients of rheumatoid arthritis and their parents
Scientific Title:Acronym A study of promoting job and study support for patients of rheumatoid arthritis and their parents
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to survey the influence of rheumatoid arthritis on job or study for the patients of rheumatoid arthritis and their support.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A change of total work or study productivity impairment and total activity impairment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 make and use a manual of preventing aggravation of rheumatoid arthritis in the workshop or school
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria rheumatoid arthritis
Key exclusion criteria nothing
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Oda
Organization Kyoto Prefectural University of Medicine
Division name Department of Orthopaedics
Zip code 6028566
Address Kawaramachi-Hirokoji, Kamigyo-ku Kyoto, 602-8566, Japan
TEL 0752515549
Email roda@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Oda
Organization Kyoto Prefectural University of Medicine
Division name Department of Orthopaedics
Zip code 6028566
Address Kawaramachi-Hirokoji, Kamigyo-ku Kyoto, 602-8566, Japan
TEL 0752515549
Homepage URL
Email roda@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JPN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine, Independent Ethics Committee
Address Kawaramachi-Hirokoji, Kamigyo-ku Kyoto, 602-8566, Japan
Tel 0752515337
Email rinri@koto.kpu-m.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

Other administrative information
Date of disclosure of the study information
2019 Year 02 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
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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 28 Day
Last modified on
2019 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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