UMIN-CTR Clinical Trial

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
Institute	Kyoto university
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038340