UMIN-CTR Clinical Trial

Basic information
Public title	A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents among the Kyoto Prefectural government employees
Acronym	A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents among the Kyoto Prefectural government employees
Scientific Title	A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents among the Kyoto Prefectural government employees
Scientific Title:Acronym	A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents among the Kyoto Prefectural government employees
Region	Japan

Condition
Condition	atopic dermatitis, bronchial asthma, food allergy
Classification by specialty	Pediatrics Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to survey the influence that chronic allergic disorders would give to job or study of the Kyoto Prefectural government employees whose children and adolescent suffer with those diseases and to promote 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	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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	their children or adolescent diagnosed with atopic dermatitis, bronchial asthma or food allergy, or their parents
Key exclusion criteria	nothing
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kunihiko Middle name Last name Tsuchiya
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pediatrics
Zip code	6028566
Address	Kawaramachi-Hirokoji, Kamigyo-ku,Kyoto, 602-8566 Japan
TEL	0752515571
Email	tsuchiya@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Kunihiko Middle name Last name Tsuchiya
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pediatrics
Zip code	6028566
Address	Kawaramachi-Hirokoji, Kamigyo-ku,Kyoto, 602-8566 Japan
TEL	0752515571
Homepage URL
Email	tsuchiya@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

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

IRB Contact (For public release)
Organization	Institutional Review Board, Kyoto Prefectural University of Medicine
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 08 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	2019 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2023 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 07 Month 13 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042602

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.