UMIN-CTR Clinical Trial

Basic information
Public title	Medical cost analysis of national health insurance and late stage medical care system for the elderly in prevention of frailty
Acronym	Medical cost analysis for prevention of frailty
Scientific Title	Medical cost analysis of national health insurance and late stage medical care system for the elderly in prevention of frailty
Scientific Title:Acronym	Medical cost analysis for prevention of frailty
Region	Japan

Condition
Condition	elderly people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the risk of frailty by using KDB data and to suggest measures against frailty.
Basic objectives2	Others
Basic objectives -Others	To clarify the risk of frailty for pre frail elderly.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	certification of long-term care insurance
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	For KDB data analysis, Study participants are aged 65 and older in National Health Insurance or medical care system for the elderly. For prefrail survey, study participants who lose 3kg weight in one year answer the questionnaire for prefrail.
Key exclusion criteria	none
Target sample size	500000

Research contact person
Name of lead principal investigator	1st name Masayo Middle name Last name Kojima
Organization	Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology
Division name	Department of Frailty Research
Zip code	4668601
Address	7-430Morioka, Obu, Aichi
TEL	0562-46-2311
Email	masayok@ncgg.go.jp

Public contact
Name of contact person	1st name Masayo Middle name Last name Kojima
Organization	Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology
Division name	Department of Frailty Research
Zip code	4668601
Address	7-430Morioka, Obu, Aichi
TEL	0562-46-2311
Homepage URL
Email	masayok@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Health Insurance & Pension Division, Health welfare Bureau, Nagoya City
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Frailty Research, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology
Address	7-430 Morioka, Obu, Aichi
Tel	0562-46-2311
Email	masayok@ncgg.go.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	2021 Year 03 Month 09 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	2021 Year 01 Month 29 Day
Date of IRB	2021 Year 01 Month 25 Day
Anticipated trial start date	2021 Year 02 Month 08 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is to analize KDB data which is national data base to identify risk of care burden. We also analyze the data for questionnaire to clarify risk of frailty. These database was anonymous data so researcher cannot identify the personal information.

Management information
Registered date	2021 Year 03 Month 09 Day
Last modified on	2021 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049310