UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037374 |
|---|---|
| Receipt number | R000042519 |
| Scientific Title | Effectiveness of a communication robot by cluster randomized controlled trial |
| Date of disclosure of the study information | 2019/07/20 |
| Last modified on | 2023/07/15 16:28:45 |
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Basic information
Public title
Effectiveness of a communication robot by cluster randomized controlled trial
Acronym
Effectiveness of a communication robot by cluster randomized controlled trial
Scientific Title
Effectiveness of a communication robot by cluster randomized controlled trial
Scientific Title:Acronym
Effectiveness of a communication robot by cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference between two groups of elderly people with dementia when PARO is applied at different frequencies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NPI-Q(Neuropsychiatric Inventory Questionnaire) for elderly people with dementia
Before and after one month intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Applying a robot for an hour per a day. Caregivers place a robot on a table in a shared space, invite subjects there and let them enjoy a robot. this froup is provided a robot once a week.
Interventions/Control_2
Applying a robot for an hour per a day. Caregivers place a robot on a table in a shared space, invite subjects there and let them enjoy a robot. this froup is provided a robot three times a week.
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
Elderly people with dementia who live in shared homes.
Key exclusion criteria
persons with skin infections, persons who dislike a robot
Target sample size
150
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
0338191211
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
+81338191211
Homepage URL
inoue@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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 Arakawa Campus
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
Tel
0338191211
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
| 2019 | Year | 07 | 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
76
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042519
