UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054329 |
|---|---|
| Receipt number | R000062065 |
| Scientific Title | Effectiveness of childhood asthma management support application "Child Asthma" |
| Date of disclosure of the study information | 2024/05/15 |
| Last modified on | 2025/03/21 13:21:28 |
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Basic information
Public title
Effectiveness of childhood asthma management support application "Child Asthma"
Acronym
Effectiveness of childhood asthma management support application "Child Asthma"
Scientific Title
Effectiveness of childhood asthma management support application "Child Asthma"
Scientific Title:Acronym
Effectiveness of childhood asthma management support application
Region
| Japan |
Condition
Condition
Pediatric Asthma
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to validate the effectiveness of smartphone app that supports tailored pediatric asthma management targeted at infants diagnosed with persistent asthma and their caregivers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Parental Childhood Asthma Self-Efficacy Scale
Key secondary outcomes
Japanese Pediatric Asthma Control test
Caregivers' pediatric asthma quality of life scale
Quality evaluation of app
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
| Behavior,custom |
Interventions/Control_1
Use of smartphone app to support childhood asthma management behaviors for caregivers
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
| 1 | months-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following eligibility criteria
1. Infant children diagnosed with bronchial asthma (0 to 6 years old) and their caregivers
2. Children who regularly attend outpatient clinics and their caregivers
3. Children with mild or persistent asthma
4. Parents using iOS (iPhone) smartphones
Key exclusion criteria
When researchers at each facility determine that participation in this study is inappropriate due to the physical and mental condition of the child or caregiver.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miori |
| Middle name | |
| Last name | Sato |
Organization
National Center for Child Health and Development
Division name
Division of allergy
Zip code
157-8535
Address
2-10-1 Okura,Setagaya-ku,Tokyo
TEL
03-3416-0181
sato-m@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Iio |
Organization
Kanto Gakuin University
Division name
College of Nursing
Zip code
236-8503
Address
1-50-1 Mutsuurahigashi,Kanazawa-ward,Yokohama,Kanagawa
TEL
045-786-5641
Homepage URL
misaiio@kanto-gakuin.ac.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Aoitori Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura,Setagaya-ku,Tokyo
Tel
03-3416-0181
sato-m@ncchd.go.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
国立成育医療研究センター（東京都）
杏林大学医学部附属病院（東京都）
公立昭和病院（東京都）
祐天寺ファミリークリニック（東京都）
東京ベイ浦安市川医療センター（千葉県）
高知大学医学部附属病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 15 | 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
14
Results
The results showed that there was no significant difference in the total score before and after the intervention for the primary endpoint, parental self-efficacy:P-CASES. However, a significant increase was observed after the intervention for sub scale III.
The secondary endpoint, JPAC, showed a significant improvement in asthma control status after the intervention. Furthermore, for the QOLCA-24, no significant improvement in the total score was observed.
Results date posted
| 2025 | Year | 03 | Month | 21 | Day |
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
| 2024 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062065
