UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059275 |
|---|---|
| Receipt number | R000067803 |
| Scientific Title | A multicenter database-based study on multifaceted analysis of home-visit and day-care rehabilitation including day-care services |
| Date of disclosure of the study information | 2025/10/03 |
| Last modified on | 2025/10/03 13:04:31 |
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Basic information
Public title
A multicenter database-based study on multifaceted analysis of home-visit and day-care rehabilitation including day-care services
Acronym
A multicenter study of home-visit and day-care rehabilitation
Scientific Title
A multicenter database-based study on multifaceted analysis of home-visit and day-care rehabilitation including day-care services
Scientific Title:Acronym
A multicenter study of home-visit and day-care rehabilitation
Region
| Japan |
Condition
Condition
older adults receiving long-term care
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct a multicenter database on home- and day-care rehabilitation services for older adults requiring care, and to conduct multifaceted analyses to generate evidence for effective rehabilitation interventions.
Basic objectives2
Others
Basic objectives -Others
Longitudinal changes and associated factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional status
Key secondary outcomes
Physical and mental functions, psychological status, motor abilities, functional status, physical activity, quality of life, and caregiver burden
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Older adults who used home- or day-care rehabilitation services, including day-care services under the long-term care insurance system, for more than 30 days between August 1, 2016 and March 31, 2029.
The primary caregivers of the above users.
Key exclusion criteria
Individuals with missing data for more than 50% of the primary outcome measures.
Individuals who opted out of participation in the study.
Individuals from whom written and verbal informed consent could not be obtained.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Ishigaki |
Organization
Kio University
Division name
Faculty of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
0745-54-1601
t.ishigaki@kio.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Ishigaki |
Organization
Kio University
Division name
Faculty of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
0745-54-1601
Homepage URL
t.ishigaki@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (Grants-in-Aid for Early-Career Scientists)
Internal research funds, 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
Research Ethics Committee, Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
Tel
0745-54-1601
kansa@kio.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 03 | 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
| 2025 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | 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
This study is a multicenter retrospective observational study. The participants are older adults in need of long-term care who used home- or day-care rehabilitation services for more than 30 days between August 1, 2016, and March 31, 2029, as well as their primary caregivers. Clinical records and rehabilitation care plans collected at each institution will be anonymized and integrated into a database managed by the coordinating institution, and longitudinal analyses will be conducted using these data.
Management information
Registered date
| 2025 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067803
