UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037365
Receipt number R000042602
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
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/17 08:51:31

* 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

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 or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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

Value
https://center6.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