UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035655
Receipt number R000038340
Scientific Title Evaluation of effect of feed back function based on connection of maternity passbook data with health check up data in young adults.
Date of disclosure of the study information 2019/01/24
Last modified on 2021/08/23 18:19:51

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Basic information

Public title

Evaluation of effect of feed back function based on connection of maternity passbook data with health check up data in young adults.

Acronym

Evaluation of effect of feed back function based on connection of maternity passbook with health check up in young adults.

Scientific Title

Evaluation of effect of feed back function based on connection of maternity passbook data with health check up data in young adults.

Scientific Title:Acronym

Evaluation of effect of feed back function based on connection of maternity passbook with health check up in young adults.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of personal health record application which includes information of infections during childhood and university health check up

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Proportion of the attendance who consult the health services during three weeks

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Push notifications by smartphone application based on medical history

Interventions/Control_2

No treatment

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Japanese students in Kyoto university who received annually health checkup, have a smart phone, and have maternity passbook.

Key exclusion criteria

People who have the smartphone which has old version of OS and mismatch with application.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iwami Taku

Organization

Agency for Health, Safety and Environment, Kyoto University

Division name

Health services

Zip code


Address

Yoshidamoto-cho,Sakyo-ku , Kyoto-shi ,Kyoto.

TEL

075-753-2426

Email

iwami.taku.8w@kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomonari Shimamoto

Organization

Agency for Health, Safety and Environment, Kyoto University

Division name

Health services

Zip code


Address

Yoshidamoto-cho,Sakyo-ku , Kyoto-shi ,Kyoto.

TEL

075-753-2433

Homepage URL


Email

kenshin_research_2018@hoken.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto university

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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


Address


Tel


Email



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

2019 Year 01 Month 24 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

Completed

Date of protocol fixation

2019 Year 01 Month 23 Day

Date of IRB

2019 Year 01 Month 24 Day

Anticipated trial start date

2019 Year 01 Month 28 Day

Last follow-up date

2020 Year 04 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 24 Day

Last modified on

2021 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038340


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name