UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043567
Receipt number R000049310
Scientific Title Medical cost analysis of national health insurance and late stage medical care system for the elderly in prevention of frailty
Date of disclosure of the study information 2021/03/09
Last modified on 2021/09/08 14:08:59

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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 or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049310