UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042825 |
|---|---|
| Receipt number | R000048891 |
| Scientific Title | Effect of home-visit rehabilitation using Management Tool for Daily Life Performance on the lives of the elderly in community dwellings. |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2020/12/23 14:55:11 |
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Basic information
Public title
A study verifying the quality of life improvement through life-focused home-visit rehabilitation of the elderly in community dwellings.
Acronym
A study verifying the quality of life improvement through life-focused home-visit rehabilitation of the elderly in community dwellings.
Scientific Title
Effect of home-visit rehabilitation using Management Tool for Daily Life Performance on the lives of the elderly in community dwellings.
Scientific Title:Acronym
Effect of home-visit rehabilitation using Management Tool for Daily Life Performance on the lives of the elderly in community dwellings.
Region
| Japan |
Condition
Condition
elderly
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of home-visit rehabilitation using the Management Tool for Daily Life Performance on the mental and physical functions, activities of daily living, instrumental activities of daily living, and quality of life of the elderly in community dwellings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Euro QOL 5 dimention
Key secondary outcomes
Barthel Index
Frenchay Activities Index
Short Physical Performance Battery
Mini-Mental State Examination-J
Achievement and satisfaction of agreed goals
Degree of care
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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 6 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
People who finished within six months from the start date
People with impaired consciousness (JCS30 or above)
People who do not agree to evaluation even if consent for research has been obtained from the proxies, mainly due to impaired consciousness or dementia.
Key exclusion criteria
People who have finished home-visit rehabilitation within six months from the start date.
Target sample size
20
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
0263-37-2405
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
0263-37-2405
Homepage URL
hitmutai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@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
| 2020 | Year | 12 | Month | 23 | 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 | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 12 | Month | 23 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048891
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
