UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047269
Receipt number R000053862
Scientific Title Randomized controlled trial to examine the effect of mobile application about the association between meteorological factors and pediatric allergy
Date of disclosure of the study information 2022/03/23
Last modified on 2025/03/27 15:01:32

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Basic information

Public title

Randomized controlled trial to examine the effect of mobile application about the association between meteorological factors and pediatric allergy

Acronym

The study to examine Availability of application between meteorological factors and pediatric allergy

Scientific Title

Randomized controlled trial to examine the effect of mobile application about the association between meteorological factors and pediatric allergy

Scientific Title:Acronym

The study to examine Availability of application between meteorological factors and pediatric allergy

Region

Japan


Condition

Condition

pediatric allergy

Classification by specialty

Pneumology Clinical immunology Pediatrics
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to establish the statistical model to predict
the status of pediatric allergy by meteorological factors and to examine
the availability of the model by randomized controlled study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Continuation rate of asthma diary

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Other

Interventions/Control_1

The provision of application to predict the status of pediatric allergy.

Interventions/Control_2

Provision of minimal information about pediatric allergy

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 years-old <=

Age-upper limit

20 years-old >

Gender

Male and Female

Key inclusion criteria

Caregivers and individuals who register the diary of pediatric asthma patients

Key exclusion criteria

non-asthmatic patient

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Saito
Middle name
Last name Naruo

Organization

Saito clinic for Asthma and Allergy children

Division name

no

Zip code

524-0022

Address

1-12-12,Moriyama,Moriyama-shi,Shiga

TEL

077-582-3110

Email

doctor@children.or.jp


Public contact

Name of contact person

1st name Zenichiro
Middle name
Last name Kawase

Organization

Japan Weather Association

Division name

Media Consumer Department

Zip code

170-6055

Address

3-1-1,Higashiikebukuro,Toshima,Tokyo

TEL

03-5958-8187

Homepage URL


Email

zen@jwa.or.jp


Sponsor or person

Institute

Saito clinic for Asthma and Allergy children

Institute

Department

Personal name



Funding Source

Organization

self-financing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

AICHI MEDICAL UNIVERSITY

Address

1-1,Yazakokarimata,Nagakute,Aichi

Tel

0561-62-3311

Email

kohtas@aichi-med-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

2022 Year 03 Month 23 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

49

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

No longer recruiting

Date of protocol fixation

2020 Year 10 Month 08 Day

Date of IRB

2020 Year 10 Month 08 Day

Anticipated trial start date

2022 Year 03 Month 24 Day

Last follow-up date

2024 Year 04 Month 01 Day

Date of closure to data entry

2024 Year 04 Month 01 Day

Date trial data considered complete


Date analysis concluded

2025 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2022 Year 03 Month 23 Day

Last modified on

2025 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053862