UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005531 |
|---|---|
| Receipt number | 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 | 2021/11/06 19:59:42 |
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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 | Taku |
| Middle name | |
| Last name | Oishi |
Organization
Kochi Medical School, Kochi University
Division name
1) Department of pediatrics 2) Department of environmental medicine
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
0888802355
takuois@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Oishi |
Organization
Kochi Medical School, Kochi University
Division name
1) Department of pediatrics 2) Department of environmental medicine
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
088-880-2355
Homepage URL
Takuois@gmail.com
Sponsor or person
Institute
Division of Allergy , National Center for Child Health and Development
Institute
Department
Personal name
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
Ethical Review Board of Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi
Tel
0888802180
is21@kochi-u.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
| 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006559
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
