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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005531
Receipt No. R000006559
Scientific Title Randomized controlled trials to certify the effectiveness of written action plans for asthmatic children in Japan.
Date of disclosure of the study information 2011/04/30
Last modified on 2014/04/29

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Basic information
Public title Randomized controlled trials to certify the effectiveness of written action plans for asthmatic children in Japan.
Acronym Written action plans for asthmatic children
Scientific Title Randomized controlled trials to certify the effectiveness of written action plans for asthmatic children in Japan.
Scientific Title:Acronym Written action plans for asthmatic children
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To certify the effect of written action plans for asthmatic children on reducing unscheduled urgent care visits and hospital admissions due to asthma exacerbation, and on improving the quality of life among their caregivers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Unscheduled urgent care visits due to asthma exacerbation.

Key secondary outcomes 1. Hospital admissions due to acute asthma exacerbation.
2. Quality of life among the caregivers of asthmatic children.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Provision of a written action plan for asthmatic children.
Interventions/Control_2 No provision of a written action plan for asthmatic children.
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
15 years-old >
Gender Male and Female
Key inclusion criteria 1) Caregivers of asthmatic patients who will need to visit our clinic regularly for more than 6 months to control their asthma.
2) Caregivers of the patients, providing written informed consent.
Key exclusion criteria 1) Caregivers of patients who had ever been given written action plans.
2) Caregivers of patients, who are unsuitable for this study due to poor familial surroundings, their own disease, or poor adherence and so on.
Target sample size 650

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Oishi
Organization Kochi Medical School, Kochi University
Division name 1) Department of pediatrics 2) Department of environmental medicine
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL 088-880-2355
Email

Public contact
Name of contact person
1st name
Middle name
Last name Taku Oishi
Organization Kochi Medical School, Kochi University
Division name 1) Department of pediatrics 2) Department of environmental medicine
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL 088-880-2355
Homepage URL
Email Takuois@gmail.com

Sponsor
Institute Division of Allergy , National Center for Child Health and Development
Institute
Department

Funding Source
Organization Environmental Restoration and Conservation Agency of Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1. National Hospital Organization, Kanagawa Hospital
2. Kera Pediatric Clinic
3. Hamamatsu University School of Medicine
4. Saitama City Hospital
5. Kinki University School of Medicine
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
2011 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2011 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
2012 Year 05 Month 01 Day
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 29 Day
Last modified on
2014 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006559

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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