UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046317 |
|---|---|
| Receipt number | R000052858 |
| Scientific Title | Study of the facial expressions of care recipients with and without the use of nursing care devices for transfer support |
| Date of disclosure of the study information | 2021/12/08 |
| Last modified on | 2022/10/21 12:30:28 |
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Basic information
Public title
Study of the facial expressions of care recipients with and without the use of nursing care devices for transfer support
Acronym
Study of the facial expressions of care recipients with and without the use of nursing care devices for transfer support
Scientific Title
Study of the facial expressions of care recipients with and without the use of nursing care devices for transfer support
Scientific Title:Acronym
Study of the facial expressions of care recipients with and without the use of nursing care devices for transfer support
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of changes in the facial expressions of care recipients by using nursing care robots
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental burden of the care recipient when using nursing care robot (Quantitative data from facial expression analysis)
Key secondary outcomes
Mental burden of caregivers when using nursing care robot (speech analysis and gaze analysis)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Installation of nursing care device using robot technology for 4 weeks/ Control_1 before installation
Interventions/Control_2
Before installation of nursing care device using robot technology
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Nursing staff (up to 40 at each facility) and their caregivers (up to 10 at each facility) at the three facilities.
2. Among them, those for which free written consent was obtained from the subject for participation in this research (if the subject is judged to be "able to express his or her own intentions," the intention to consent will be confirmed using plain language or drawings, etc., and the consent form will state that assent was obtained).
3. In cases where it is difficult to obtain consent from the care recipient, a family member should sign as a substitute after sufficient explanation.
Key exclusion criteria
1. The exclusion criteria are the same as the application criteria for the commercial devices; Hug has no application criteria on the part of the caregivers, and care recipients weighing 100 kg or more and those who cannot sit up are excluded. There are no specific exclusion criteria for Resyone.
2. Other persons who are deemed inappropriate by the Research Director or Research Divider.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kato |
Organization
National Center for Geriatrics and Gerontology
Division name
Laboratory for Clinical Evaluation with Robotics, Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
Homepage URL
kk0724@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Assistive Robot Center, National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
Tel
0562462311
ik7710@ncgg.go.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
１．指定介護老人福祉施設 愛厚ホーム大府苑（愛知県）
２．住宅型有料老人ホーム さわやかの丘（愛知県）
３．介護付有料老人ホーム フラワーサーチ大府（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052858
| 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 |
