UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036628 |
|---|---|
| Receipt number | R000041729 |
| 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 |
| Date of disclosure of the study information | 2019/04/30 |
| Last modified on | 2019/04/30 11:49:51 |
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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
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
yamaya.soccer22@gmail.com
Public contact
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
yamaya.soccer22@gmail.com
Sponsor or person
Institute
Kochi Medical School University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041729
