UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037794
Receipt number R000043101
Scientific Title About the relationship between the presence or absence of falls of elderly people requiring support and nursing care and the situation of the house
Date of disclosure of the study information 2019/08/25
Last modified on 2019/08/25 19:05:42

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Basic information

Public title

About the relationship between the presence or absence of falls of elderly people requiring support and nursing care and the situation of the house

Acronym

About the relationship between the presence or absence of falls of elderly people requiring support and nursing care and the situation of the house

Scientific Title

About the relationship between the presence or absence of falls of elderly people requiring support and nursing care and the situation of the house

Scientific Title:Acronym

About the relationship between the presence or absence of falls of elderly people requiring support and nursing care and the situation of the house

Region

Japan


Condition

Condition

Elderly people who need nursing care / support required

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the relationship between the fall history and status of the certified homes requiring assistance / care, and clarify the relationship

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Whether there is a fall

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who can move by themselves with an independence level of B2 or higher

Key exclusion criteria

Those who are bedridden with independence C1 and C2

Target sample size

300


Research contact person

Name of lead principal investigator

1st name sakano
Middle name
Last name yuya

Organization

Kio university

Division name

Health Science

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara

TEL

0745-54-1601

Email

yuya_sakano@yahoo.co.jp


Public contact

Name of contact person

1st name sakano
Middle name
Last name yuya

Organization

Kio university

Division name

Health Science

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara

TEL

0745-54-1601

Homepage URL


Email

yuya_sakano@yahoo.co.jp


Sponsor or person

Institute

Kio university

Institute

Department

Personal name



Funding Source

Organization

Kio university

Organization

Division

Category of Funding Organization

Other

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 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara

Tel

0745-54-1601

Email

yuya_sakano@yahoo.co.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

2019 Year 08 Month 25 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

Preinitiation

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing especially


Management information

Registered date

2019 Year 08 Month 25 Day

Last modified on

2019 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043101


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name