UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025673 |
|---|---|
| Receipt number | R000029537 |
| Scientific Title | Effect of communication robots coordinated with monitoring system on elderly people care at nursing home |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2020/01/17 20:39:27 |
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Basic information
Public title
Effect of communication robots coordinated with monitoring system on elderly people care at nursing home
Acronym
Effect of communication robots coordinated with monitoring system on elderly people care at nursing home
Scientific Title
Effect of communication robots coordinated with monitoring system on elderly people care at nursing home
Scientific Title:Acronym
Effect of communication robots coordinated with monitoring system on elderly people care at nursing home
Region
| Japan |
Condition
Condition
Elderly care at nursing home
Classification by specialty
| Geriatrics | Rehabilitation medicine | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of communication robots coordinated with monitoring system on elderly people 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
WHODAS2.0 and MMSE-J 4weeks later, 8weeks later
Key secondary outcomes
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
robot A(+) and B(-) for 8 weeks
Interventions/Control_2
robot A(-) and B(+) for 8 weeks
Interventions/Control_3
robot A(-) and B(-) for 16 weeks
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
the elderly
Key exclusion criteria
Subjects with severe dementia or severe apasia who cannot make communication.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Obayashi |
Organization
Social Welfare Corporation Tokyo Seishinkai
Division name
Flora Tanashi
Zip code
188-0013
Address
2-16-25, Mukoudaicho, Nishitokyo, Tokyo, Japan
TEL
+81-42-468-2311
kakkoro114@gmail.com
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Obayashi |
Organization
Social Welfare Corporation Tokyo Seishinkai
Division name
Flora Tanashi
Zip code
188-0013
Address
2-16-25, Mukoudaicho, Nishitokyo, Tokyo, Japan
TEL
+81-42-468-2311
Homepage URL
kakkoro114@gmail.com
Sponsor or person
Institute
Social Welfare Corporation Tokyo Seishinkai
Institute
Department
Personal name
Funding Source
Organization
Social Welfare Corporation Tokyo Seishinkai
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Universal Accessibility Evaluation Organization
Tokyo Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social Welfare Corporation Tokyo Seishinkai
Address
2-16-25, Mukoudaicho, Nishitokyo, Tokyo, Japan
Tel
+81-42-468-2311
inutake@tokyo-seishinkai.or.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
社会福祉法人東京聖新会（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.jamda.2018.02.015
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1016/j.jamda.2018.02.015
Number of participants that the trial has enrolled
Results
Obayashi K., Kodate N. and Masuyama S. Socially assistive robots and their potential in enhancing older people's activity and social participation JAMDA May 2018 Volume 19, Issue 5, Pages 462-463
Obayashi K., Kodate N. and Masuyama S. Enhancing Older People's Activity and Participation with Socially Assistive Robots: A Multicentre Quasi-Experimental Study using the ICF Framework. Advanced Robotics 2018, vol. 32, No. 22, 1207-1216
Results date posted
| 2020 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Obayashi K., Kodate N. and Masuyama S. Enhancing Older People's Activity and Participation with Socially Assistive Robots: A Multicentre Quasi-Experimental Study using the ICF Framework. Advanced Robotics 2018, vol. 32, No. 22, 1207-1216
Participant flow
Obayashi K., Kodate N. and Masuyama S. Enhancing Older People's Activity and Participation with Socially Assistive Robots: A Multicentre Quasi-Experimental Study using the ICF Framework. Advanced Robotics 2018, vol. 32, No. 22, 1207-1216
Adverse events
Obayashi K., Kodate N. and Masuyama S. Enhancing Older People's Activity and Participation with Socially Assistive Robots: A Multicentre Quasi-Experimental Study using the ICF Framework. Advanced Robotics 2018, vol. 32, No. 22, 1207-1216
Outcome measures
Obayashi K., Kodate N. and Masuyama S. Enhancing Older People's Activity and Participation with Socially Assistive Robots: A Multicentre Quasi-Experimental Study using the ICF Framework. Advanced Robotics 2018, vol. 32, No. 22, 1207-1216
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2016 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Kazuko Obayashi, Shigeru Masuyama, Takaya Ogata, Yoshiko Okamoto, Kosuke Tateno, Toshiyuki Fudoda, Satoshi Harada, Yoko Ishii. Does a Communicative Care Robot in Nursing Homes Improve Older Peoples Activity Performance? Non Randomised Controlled Trial using the ICF Framework. Age and Ageing, Volume 46, Issue Suppl_3, 1 September 2017, Pages iii1-iii12
Obayashi K., Kodate N. and Masuyama S. Do age, gender and stage of dementia matter in the intervention study of communicative robots? An assessment of their impact in older people homes Age and Ageing 47(suppl_5): v13-v60, September 2018 DOI:10.1093/ageing/afy140.18
Management information
Registered date
| 2017 | Year | 01 | Month | 14 | Day |
Last modified on
| 2020 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029537
