UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030893 |
|---|---|
| Receipt number | R000035275 |
| Scientific Title | Effect of communication robot "Hello Babies" on elderly care at nursing home |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2019/01/25 14:59:59 |
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Basic information
Public title
Effect of communication robot "Hello Babies" on elderly care at nursing home
Acronym
Effect of communication robot "Hello Babies" on elderly care at nursing home
Scientific Title
Effect of communication robot "Hello Babies" on elderly care at nursing home
Scientific Title:Acronym
Effect of communication robot "Hello Babies" on elderly care at nursing home
Region
| Japan |
Condition
Condition
Elderly care
Classification by specialty
| Geriatrics | Psychiatry | Rehabilitation medicine |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of communication robot "Hello Babies" on elderly care at nursing home
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychological response
Key secondary outcomes
Change of Depressive state
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
communication robots for 4 weeks
Interventions/Control_2
normal doll
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age between 65 and 95 ears old
Key exclusion criteria
severe dementia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuko Obayashi |
Organization
Social Welfare Corporation Tokyo Seishinkai
Division name
Flora Tanashi
Zip code
Address
Mukodai 2-16-22 NishiTokyo, Tokyo Japan
TEL
+81-42-468-2311
kakkoro114@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Masuyama |
Organization
Tokyo Medical University Hospital
Division name
Travellers Medical Center
Zip code
Address
6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL
+81-3-533903726
Homepage URL
s_masu@tokyo-med.ac.jp
Sponsor or person
Institute
Social Welfare Corporation Tokyo Seishinkai
Institute
Department
Personal name
Funding Source
Organization
The Association for Technical Aid
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Universal Accessibility Evaluation Organization
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
東京聖新会(東京都)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 25 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035275
| 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 |
