UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043109
Receipt number R000049184
Scientific Title Validity of physical function assessment in nursing care prevention facilities for frail community dwellers
Date of disclosure of the study information 2021/02/01
Last modified on 2022/11/30 21:01:45

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Basic information

Public title

Assessment of physical function in people using nursing care prevention facilities

Acronym

Assessment of physical function in people using nursing care prevention facilities

Scientific Title

Validity of physical function assessment in nursing care prevention facilities for frail community dwellers

Scientific Title:Acronym

Validity of physical function assessment in nursing care prevention facilities for frail community dwellers

Region

Japan


Condition

Condition

Community dwellers who are using nursing care prevention facilities

Classification by specialty

Geriatrics Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate prospectively the influence of parameters obtained over time through the efforts of long-term care prevention facilities on the physical function, activity level, frailty, and prognosis

Basic objectives2

Others

Basic objectives -Others

Validity

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

All-cause mortality at 1-, 2-, 3-, and 5-year after the start of facility use

Key secondary outcomes

Quality Adjusted Life Year (QALY)
Canadian Occupational Performance Measure (COPM)
Hospitalization events for all-causes
Changes in various physical function parameters, care levels, and frailty


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Community dwellers who have started using the nursing care prevention facility "UP Life"

Key exclusion criteria

Not given consent

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Kentaro
Middle name
Last name Kamiya

Organization

Kitasato University School of Allied Health Sciences

Division name

Department of Rehabilitation

Zip code

252-0375

Address

1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan

TEL

0427789693

Email

k-kamiya@kitasato-u.ac.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Yamashita

Organization

Kitasato University Graduate School of Medical Sciences

Division name

Department of Rehabilitation Sciences

Zip code

252-0375

Address

1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan

TEL

0427789081

Homepage URL


Email

mss.yamashita.pt@gmail.com


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

ARCE Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Research Ethics Committee of Kitasato University School of Allied Health Sciences

Address

1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan

Tel

0427789602

Email

a-soumu@kitasato-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

介護予防施設 UP Life


Other administrative information

Date of disclosure of the study information

2021 Year 02 Month 01 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

Open public recruiting

Date of protocol fixation

2020 Year 12 Month 02 Day

Date of IRB

2020 Year 12 Month 02 Day

Anticipated trial start date

2020 Year 12 Month 02 Day

Last follow-up date

2025 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The last follow-up date of this study is planned to be until October 31, 2025, but the inclusion of subjects and the follow-up period will be extended if necessary, with the approval of the Ethical Review Committee.


Management information

Registered date

2021 Year 01 Month 23 Day

Last modified on

2022 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049184


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name