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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035053
Receipt No. R000039964
Scientific Title Study to promote employment and enrollment support of patients with bronchial asthma and their carers
Date of disclosure of the study information 2019/01/01
Last modified on 2018/11/28

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Basic information
Public title Study to promote employment and enrollment support of patients with bronchial asthma and their carers
Acronym Research on employment and school attendance of family members of asthma patients
Scientific Title Study to promote employment and enrollment support of patients with bronchial asthma and their carers
Scientific Title:Acronym Research on employment and school attendance of family members of asthma patients
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is to investigate the current situation of bronchial asthma on the employment and enrollment of patients and caregivers, to propose and disseminate its support system.
Basic objectives2 Others
Basic objectives -Others Preparation of support manuals for patients / caregivers, workplaces, schools
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survey on difficult situation on employment and enrollment in patients with bronchial asthma.
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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Questionnaire survey
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 1. A patient whose principal or his / her family is diagnosed with bronchial asthma.
2. Patient who can answer questionnaire survey.
3 Patients over the age of 15.
4. Patient who got consent of the person concerned about participation in research.
Key exclusion criteria 1. Patients who are unable to obtain written informed consent for participation in this study.
2. Patient who can not respond to questionnaire due to dementia.
3. Patient judged to be inapplicable by research doctor.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Takayama
Organization Kyoto Prefectural University of Medicine
Division name respiratory medecine
Zip code
Address Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL 075-251-5513
Email kaneko-y@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiko Kaneko
Organization Kyoto Prefectural University of Medicine
Division name respiratory medecine
Zip code
Address Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL 075-251-5513
Homepage URL
Email kaneko-y@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
Address
Tel
Email

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 01 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 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 28 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039964

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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