UMIN-CTR Clinical Trial

Basic information
Public title	Survey on Fall Status, Physical Function, Attention Function, and Certification of Long-term Care for Elderly Persons Attending Specific Medical Examination-From the viewpoint of flail and social flail
Acronym	Survey on Fall Status, Physical Function, Attention Function, and Certification of Long-term Care for Elderly Persons Attending Specific Medical Examination-From the viewpoint of flail and social flail
Scientific Title	Survey on Fall Status, Physical Function, Attention Function, and Certification of Long-term Care for Elderly Persons Attending Specific Medical Examination-From the viewpoint of flail and social flail
Scientific Title:Acronym	Survey on Fall Status, Physical Function, Attention Function, and Certification of Long-term Care for Elderly Persons Attending Specific Medical Examination-From the viewpoint of flail and social flail
Region	Japan

Condition
Condition	Elderly people
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In recent years, the percentage of elderly people living alone and in couples alone has increased, and the need for social flair surveys is also increasing. This time, we decided to compare the number of falls in one year, attention function, physical function, and the presence or absence of nursing care certification for those with social flail and those without social flail (including prefrail).
Basic objectives2	Others
Basic objectives -Others	Persons with social flail may have impaired physical function and / or impaired attention function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of falls in a year
Key secondary outcomes	physical function attention function Required nursing care status

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	Elderly person in Frail (including Preflail)
Key exclusion criteria	Dementia person Person who can not walk Person who has motor paralysis
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Takahiro Middle name Last name Yamamoto
Organization	Kochi Medical School University
Division name	Department of Rehabilitation Center
Zip code	783-8505
Address	Kohasu,Oko-cho,Nankoku,Kochi,Japan
TEL	088-880-2490
Email	yamaya.soccer22@gmail.com

Public contact
1st name of contact person	1st name Takahiro Middle name Last name Yamamoto
Organization	Kochi Medical School University
Division name	Department of Rehabilitation Center
Zip code	783-8505
Address	Kohasu,Oko-cho,Nankoku,Kochi,Japan
TEL	088-880-2490
Homepage URL
Email	yamaya.soccer22@gmail.com

Sponsor
Institute	Kochi Medical School University
Institute
Department

Funding Source
Organization	No provider
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	Kochi Medical School University
Address	Kohasu,Oko-cho,Nankoku,Kochi,Japan
Tel	088-880-2490
Email	yamaya.soccer22@gmail.com

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 04 Month 30 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	Enrolling by invitation
Date of protocol fixation	2018 Year 10 Month 23 Day
Date of IRB	2018 Year 10 Month 23 Day
Anticipated trial start date	2018 Year 10 Month 30 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Evaluation item: Number of falls (one year) Attention function (TMT-B) Physical function (chair sitting test, walking test) Required nursing care status Basic Checklist

Management information
Registered date	2019 Year 04 Month 30 Day
Last modified on	2019 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041729