UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022992 |
|---|---|
| Receipt number | R000025967 |
| Scientific Title | Algorithm verification of facilities and visit type services for the prevention day care users |
| Date of disclosure of the study information | 2016/07/07 |
| Last modified on | 2017/03/07 19:09:38 |
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Basic information
Public title
Algorithm verification of facilities and visit type services for the prevention day care users
Acronym
Algorithm verification of prevention services for day care users
Scientific Title
Algorithm verification of facilities and visit type services for the prevention day care users
Scientific Title:Acronym
Algorithm verification of prevention services for day care users
Region
| Japan |
Condition
Condition
Geriatrics
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the prophylactic efficacy of home-visiting occupational therapy, provided additional to day service, that focuses on daily life activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Assessment of Motor and Process Skills
SF-12
EQ-5D-5L
Barthel Index
Frenchay Activities Index
Budget
Key secondary outcomes
Mini Mental State Examination
TMIG-IC
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Three times or more over a three month period. Intervention pertains to instruction/practice of daily life performance. Intervention conducted in the places of the research subject's choice (home, community).
Interventions/Control_2
no treatment
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
Subjects entitled to long-term care insurance community support home-visiting service C
Key exclusion criteria
Excluded are persons receiving home visiting rehabilitation by occupational therapist and/or physiotherapist.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Ishibashi |
Organization
Tokyo Metropolitan University
Division name
Division of Occupational Therapy
Zip code
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
81-3-3819-1211
yu-ishi@tmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Ishibashi |
Organization
Tokyo Metropolitan University
Division name
Division of Occupational Therapy
Zip code
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
81-3-3819-1211
Homepage URL
yu-ishi@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University,Department of Human Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 07 | Month | 07 | 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
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 03 | Day |
Last modified on
| 2017 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025967
