UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057153 |
|---|---|
| Receipt number | R000054773 |
| Scientific Title | The effect of home-visit rehabilitation focusing on "activities" and "participation" on the activities of daily life performance of community-dwelling elderly |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/08/29 13:40:49 |
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Basic information
Public title
A study to examine whether quality of life improves for community-dwelling elderly in the home-visit rehabilitation focusing on daily living and social participation
Acronym
A study to examine whether quality of life improves for community-dwelling elderly in the home-visit rehabilitation focusing on daily living and social participation
Scientific Title
The effect of home-visit rehabilitation focusing on "activities" and "participation" on the activities of daily life performance of community-dwelling elderly
Scientific Title:Acronym
The effect of home-visit rehabilitation focusing on "activities" and "participation" on the activities of daily life performance of community-dwelling elderly
Region
| Japan |
Condition
Condition
Elderly people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of an intervention focusing on "activity" and "participation" by home-visit rehabilitation on physical function, mental function, ADL, IADL, quality of life, care burden, and the amount of Long-term care insurance utilization for community-dwelling elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Euro QOL 5 dimension
Key secondary outcomes
Frenchay Activities Index
Barthel Index
Short Physical Performance Battery
Mini-Mental State Examination-J
Longterm care degree
Type and frequency of services used
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The Management Tool for Daily Life Performance will be used to determine life-focused interventions for elderly people living in the community dwellings and interventions by home-visit rehabilitation will be conducted once or twice a week for 12 months.
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
Individuals who newly start home-visit rehabilitation
Individuals who are 65 years of age or older at the time of obtaining consent
Individuals who have received sufficient explanation of their participation in this study and have obtained written consent based on the free will of the participant or a surrogate.
Key exclusion criteria
Individuals with impaired consciousness (JCS10 or above)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372405
hitmutai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372405
Homepage URL
hitmutai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
The society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Azumino Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263372405
hitmutai@shinshu-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054773
