UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039204 |
|---|---|
| Receipt number | R000044709 |
| Scientific Title | Survey of staff's physical and psychological burden and behavior from the level of proficiency regarding the use of transfer support robot |
| Date of disclosure of the study information | 2020/01/21 |
| Last modified on | 2020/01/20 15:14:34 |
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Basic information
Public title
Survey of staff's physical and psychological burden and behavior from the level of proficiency regarding the use of transfer support robot
Acronym
Survey of burden and behavior of staff by skill of using transfer support robot
Scientific Title
Survey of staff's physical and psychological burden and behavior from the level of proficiency regarding the use of transfer support robot
Scientific Title:Acronym
Survey of burden and behavior of staff by skill of using transfer support robot
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of introduction effect of transfer support robot care equipment in care facility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical and psychological burden of care workers and flow of work (Early, middle and after use of robots)
Key secondary outcomes
Changes in nursing care services due to device proficiency
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Before using transfer support robot equipment
Interventions/Control_2
Immediately after using transfer support robot equipment (1 or 2 weeks)
Interventions/Control_3
After mastering the use of transfer support robot equipment (From 5 weeks to mastery)
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. Up to 20 long-term care workers in facilities that are familiar with four types of transfer support robots (maximum of 80 people in four models), up to 20 long-term care workers in facilities that are not familiar with them (maximum of 80 people in four models), and care recipients (Maximum 10 people each: Up to 80 people in the above 8 facilities)
2. Among them, the consent of the document was obtained with the free will of the person who participated in this study.
3. However, for the cared person, select a person who has consent ability (score 3 or higher) using a test (Mini-cog) that can evaluate cognitive function.
Key exclusion criteria
1. Patients with a history of brain disease, neurological/muscular disease, heart disease, epilepsy
2. Having a pacemaker
3. Pregnant women
4. Other persons who are deemed inappropriate by the Research Director or Research Divider
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Centre for Geriatrics and Gerontology
Division name
Centre of Assistive Robotics and Rehabilitation for Longevity and Good Health
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 Centre for Geriatrics and Gerontology
Division name
Lab Clinical Evaluation with Robotics, Centre of Assistive Robotics and Rehabilitation for Longevity
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 Centre for Geriatrics and Gerontology,
Lab Clinical Evaluation with Robotics, Centre of Assistive Robotics and Rehabilitation for Longevity and Good Health
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fujita Health University, School of Health Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Centre 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
介護老人福祉施設 長寿の里・十四山 （愛知県）、特別養護老人ホーム 南さいわい（神奈川県）、特別養護老人ホーム みのりの里いいとみ（山梨県）、特別養護老人ホーム 砧ホーム（東京都）、指定介護老人福祉施設 愛厚ホーム大府苑（愛知県）、住宅型有料老人ホーム さわやかの丘（愛知県）、特別養護老人ホーム クロスハート幸・川崎（神奈川県）、介護老人保健施設 万年青苑（長野県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 21 | 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
107
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 01 | Month | 20 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044709
| Research Plan | |
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| 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 |
