UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043881