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 | 2025/03/21 08:23:08 |
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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
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
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
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
| 2029 | Year | 03 | 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
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049184
