UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039185
Receipt number R000044689
Scientific Title Dynamic investigation of allergic symptoms using smartphone application
Date of disclosure of the study information 2020/01/17
Last modified on 2022/12/09 11:06:02

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Basic information

Public title

Dynamic investigation of allergic symptoms using smartphone application

Acronym

Dynamic investigation of allergic symptoms using smartphone application

Scientific Title

Dynamic investigation of allergic symptoms using smartphone application

Scientific Title:Acronym

Dynamic investigation of allergic symptoms using smartphone application

Region

Japan Europe


Condition

Condition

allergic rhinitis
asthma

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to coollect the records on allergic symptoms using a smartphone application and use the data obtained from the application to investigate the current status of allergic symptoms and treatments in Japan.

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Observational study

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

The target person are as below;

People who downloads the application distributed free of charge,
People who understands the "Research Agreement and Terms of Use", and
People who obtains the agreement.
The subject is random and uses a smartphone.

Key exclusion criteria

People under 18 are excluded.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Tomohisa
Middle name
Last name Iinuma

Organization

Chiba university hospital

Division name

Department of Otolaryngology

Zip code

260856

Address

1-8-1 inohana chuoku chiba

TEL

810432227171

Email

iinuma-t@chiba-u.jp


Public contact

Name of contact person

1st name Tomohisa
Middle name
Last name Iinuma

Organization

Chiba university hospital

Division name

Department of Otolaryngology

Zip code

260856

Address

1-8-1 inohana chuoku chiba

TEL

810432227171

Homepage URL


Email

iinuma-t@chiba-u.jp


Sponsor or person

Institute

Chiba university

Institute

Department

Personal name



Funding Source

Organization

Japanese Society of Allergology

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Graduate School of Medicine Ethics board

Address

1-8-1 inohana chuoku chiba

Tel

0432227171

Email

igaku-rinri@office.chiba-u.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

2020 Year 01 Month 17 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


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

Open public recruiting

Date of protocol fixation

2019 Year 10 Month 01 Day

Date of IRB

2019 Year 09 Month 20 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We want to collect the records on allergic symptoms using a smartphone application and use the data obtained from the application to investigate the current status of allergic symptoms and treatments in Japan.
After downloading, subjects enter their profile (gender, age, nationality, language, presence or absence of allergic rhinitis or bronchial asthma, type of drug used, smoking), then daily diary of allergy symptoms (eye, nose, airway symptoms, etc.) The effect of the symptoms on work and sleep) must be entered in a VAS scale or the like like a diary.


Management information

Registered date

2020 Year 01 Month 17 Day

Last modified on

2022 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044689


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name