UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039058 |
|---|---|
| Receipt number | R000043881 |
| Scientific Title | Feasibility study of tailored smartphone app in childhood asthma |
| Date of disclosure of the study information | 2020/03/02 |
| Last modified on | 2021/10/11 11:18:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility study of smartphone app in childhood asthma
Acronym
Feasibility study of smartphone app in childhood asthma
Scientific Title
Feasibility study of tailored smartphone app in childhood asthma
Scientific Title:Acronym
Feasibility study of tailored smartphone app in childhood asthma
Region
| Japan |
Condition
Condition
Childhood asthma
Classification by specialty
| Pediatrics | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of the newly developed smartphone app for tailored patient education for childhood asthma.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility and usefulness of apps 24 weeks after study registration and number of access to apps 24 weeks after study registration.
Key secondary outcomes
App involvement, satisfaction, behavior change and continuation
Reference level of tailored messages
Universal design
Most used and unused content
What content of the app you use mainly
How to use the 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
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Have the child's asthma app downloaded on the parent's smartphone.
Continue to manage childhood asthma self-management behavior, using the app regularly at a personal pace for 24 weeks after study registration.
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children (0 to 12 years old) who are diagnosed as bronchial asthma by doctors and go to outpatients and their caregivers.
Child with persistent asthma.
Age of onset, duration of treatment, and treatment content do not matter.
Caregiver uses smartphone.
Key exclusion criteria
When researchers at each institution determine that participation in this study is inappropriate due to the mental and physical condition of the child or caregiver.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Misa |
| Middle name | |
| Last name | Iio |
Organization
Kanto Gakuin University
Division name
College of Nursing
Zip code
2368503
Address
1-50-1 Mutsuurahigashi, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457865641
misaiio@kanto-gakuin.ac.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
2368503
Address
1-50-1 Mutsuurahigashi, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457865641
Homepage URL
misaiio@kanto-gakuin.ac.jp
Sponsor or person
Institute
Kanto Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (B)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Tokyo Metropolitan Children's Medical Center
Kochi Medical School
Tokyo Bay Urayasu Ichikawa Medical Center
Inagaki clinic
Yutenji Family Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanto Gakuin University
Address
1-50-1 Mutsuurahigashi, Kanazawa-ku, Yokohama, Kanagawa
Tel
0457865641
misaiio@kanto-gakuin.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
国立成育医療研究センター（東京都）
東京都立小児総合医療センター（東京都）
高知大学医学部附属病院（高知県）
公立昭和病院（東京都）
東京ベイ浦安市川医療センター（千葉県）
いながきクリニック（東京都）
祐天寺ファミリークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 02 | 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
30
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
| 2020 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 01 | Month | 06 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043881
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
