UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039473 |
|---|---|
| Receipt number | R000045008 |
| Scientific Title | The effects of communication robot activity for elderly persons with dementia |
| Date of disclosure of the study information | 2020/02/20 |
| Last modified on | 2022/02/16 16:40:33 |
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Basic information
Public title
The effects of communication robot activity for elderly persons with dementia
Acronym
The effects of communication robot activity for elderly persons with dementia
Scientific Title
The effects of communication robot activity for elderly persons with dementia
Scientific Title:Acronym
The effects of communication robot activity for elderly persons with dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to analyze when a communication robot is used by family members living at home with an elderly person with dementia, the effectiveness of care by family members that can be expected and to identify the priorities of problems to be solved from the results.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Profiles of elderly people, observation results of elderly people, results of interviews with family members
Key secondary outcomes
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
| Other |
Interventions/Control_1
Robot activity to the elderly by their family
3 times or more per week
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly people with dementia living at home, Families living with them can handle a robot.
Key exclusion criteria
the elderly who refuse the robot
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Inoue |
Organization
Tokyo Metropolitan University
Division name
Faculty of Health Sciences
Zip code
1168551
Address
7-2-10,Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
inoue@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Inoue |
Organization
Tokyo Metropolitan University
Division name
Faculty of Health Sciences
Zip code
1168551
Address
7-2-10,Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
inoue@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
Tel
03-3819-1211
inoue@tmu.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 | 02 | Month | 20 | 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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The paper is being submitted to the journal
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | 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 | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045008
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
