UMIN-CTR Clinical Trial

Basic information
Public title	The formation of comprehensive community care system research base by social capital creation and health care data centralization, KAGUYA project: The survey for older adults
Acronym	The KAGUYA project survey for older adults
Scientific Title	The formation of comprehensive community care system research base by social capital creation and health care data centralization, KAGUYA project: The survey for older adults
Scientific Title:Acronym	The KAGUYA project survey for older adults
Region	Japan

Condition
Condition	Healthy older adults
Classification by specialty	Medicine in general Geriatrics Rehabilitation medicine Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of KAGUYA project are (1) to advance the consolidation centralized healthcare data in cooperation with the Koryo-cho, (2) to build the study base by framework data storage, (4) to promote as a means of human resource development on how to approach and data utilization practices to data grasp difficult person was the challenge of data health and (5) to clarify whether to contribute to the promotion of health and nursing care and dementia prevention of residents. The purpose of this study is to observe the social capital and the health index of Koryo-cho living elderly living more than 65 years the elderly,in order to achieve the various objectives in KAGUYA project.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Healthy life expectancy from the baseline survey
Key secondary outcomes	New falling, fracture, depression and certification of long term care after three years from the baseline survey Social capital index

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Training the residents leader for the care prevention, the student health support team and the dementia supporter, holding of dementia cafe and Application development related to health and dementia
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy older adults
Key exclusion criteria	People who are hospitalized or in nursing home
Target sample size	6800

Research contact person
Name of lead principal investigator	1st name Jongseong Middle name Last name Moon
Organization	Kio University
Division name	Facuty of health science
Zip code	635-0832
Address	635-0832
TEL	08038593921
Email	j.moon@kio.ac.jp

Public contact
Name of contact person	1st name Jong-Seong Middle name Last name Moon
Organization	Kio University
Division name	Faculty of health scince
Zip code	635-0832
Address	635-0832
TEL	0745-54-1602
Homepage URL
Email	j.moon@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kio University
Address	4-2-2, Umami-Naka, Koryo, Nara, Japan
Tel	0745541601
Email	soumu@kio.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	2015 Year 11 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	No longer recruiting
Date of protocol fixation	2015 Year 11 Month 20 Day
Date of IRB	2015 Year 12 Month 03 Day
Anticipated trial start date	2016 Year 01 Month 10 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	Healthy older adults over the age of 65 living in the Koryo town

Management information
Registered date	2015 Year 11 Month 16 Day
Last modified on	2021 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022794