UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045919
Receipt number R000052400
Scientific Title Development of a research field for the demonstration of long-term care prevention services through the construction of an ICT platform
Date of disclosure of the study information 2021/10/31
Last modified on 2023/05/02 08:24:53

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Basic information

Public title

Development of a research field for the demonstration of long-term care prevention services through the construction of an ICT platform

Acronym

Development of a research field for the demonstration of long-term care prevention services through the construction of an ICT platform

Scientific Title

Development of a research field for the demonstration of long-term care prevention services through the construction of an ICT platform

Scientific Title:Acronym

Development of a research field for the demonstration of long-term care prevention services through the construction of an ICT platform

Region

Japan


Condition

Condition

fracture, pneumonia, dementia, frailty

Classification by specialty

Medicine in general Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We construct a linkage method between the measurement results of gait measurement, saliva measurement, and life log measurement, and the medical receipt data and nursing care receipt data of the subject.

Basic objectives2

Others

Basic objectives -Others

We use the linkage data to examine the relationship between the data and the health status of elderly people.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

healthy life expectancy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Gait measurement, saliva measurement, lifelog measurement

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Elderly people who participate in group health checkups and care prevention classes in the local governments that cooperated in this study, and who have given written consent.

Key exclusion criteria

N/A

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Haruhisa
Middle name Fukuda
Last name Fukuda

Organization

Kyushu University

Division name

Graduate School of Medical Sciences

Zip code

812-8582

Address

Maidashi 3-1-1 Higashi-ku Fukuoka

TEL

0926426960

Email

h_fukuda@hcam.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Haruhisa
Middle name
Last name Fukuda

Organization

Kyushu University

Division name

Graduate School of Medical Sciences

Zip code

812-8582

Address

Maidashi 3-1-1 Higashi-ku Fukuoka

TEL

0926426960

Homepage URL


Email

h_fukuda@hcam.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

AMED

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

Kyushu University Hospital Ethics Review Committee

Address

Maidashi 3-1-1 Higashi-ku Fukuoka

Tel

092-642-5082

Email

byskenkyu@jimu.kyushu-u.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

2021 Year 10 Month 31 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

562

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

2021 Year 10 Month 11 Day

Date of IRB

2021 Year 10 Month 14 Day

Anticipated trial start date

2021 Year 11 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 10 Month 29 Day

Last modified on

2023 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052400