UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035839 |
|---|---|
| Receipt number | R000040826 |
| Scientific Title | A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents. |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2019/07/13 16:38:26 |
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Basic information
Public title
A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents.
Acronym
A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents.
Scientific Title
A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents.
Scientific Title:Acronym
A study of promoting job and study support for children and adolescent with chronic allergic diseases and their parents.
Region
| Japan |
Condition
Condition
atopic dermatitis, bronchial asthma or food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to survey the influence of chronic allergic diseases on job or study for the children and adolescent with chronic allergic diseases and their parents 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
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
To make and use a manual of preventing aggravation of atopic dermatitis in the workplace 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
children or adolescent diagnosed with atopic dermatitis, bronchial asthma or food allergy, or their parents
Key exclusion criteria
nothing
Target sample size
300
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
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
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
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 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 07 | 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 | 02 | Month | 11 | Day |
Last modified on
| 2019 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040826
