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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039058
Receipt No. 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 2021/05/01

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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
Email 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
Email misaiio@kanto-gakuin.ac.jp

Sponsor
Institute Kanto Gakuin University
Institute
Department

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
Email 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 34
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 05 Month 01 Day


Link to view the page
URL(English) https://upload.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


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