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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039203
Receipt No. R000044708
Scientific Title Survey of staff's physical and psychological burden and time required for various assistance according to proficiency level of transfer support robot
Date of disclosure of the study information 2020/01/21
Last modified on 2021/01/12

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Basic information
Public title Survey of staff's physical and psychological burden and time required for various assistance according to proficiency level of transfer support robot
Acronym Survey of staff's burden and time for various assistance according to proficiency level of transfer support robot
Scientific Title Survey of staff's physical and psychological burden and time required for various assistance according to proficiency level of transfer support robot
Scientific Title:Acronym Survey of staff's burden and time for various assistance according to proficiency level of 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, 4 weeks after using the robot
Key secondary outcomes Changes in time required for nursing care as devices become more proficient

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 4 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. Targets up to 20 caregivers at facilities that are familiar with the transfer support robot Hug, up to 20 caregivers at facilities that are unfamiliar with them, and their care recipients (up to 10 each)
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 users, a person with consent (score 3 or higher) is selected 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 60

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
TEL 0562462311
Email 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 Centre of Assistive Robotics and Rehabilitation for Longevity and Good Health
Zip code 4748511
Address 7-430, Morioka, Obu, Aichi
TEL 0562462311
Homepage URL
Email kk0724@ncgg.go.jp

Sponsor
Institute National Centre for Geriatrics and Gerontology,

Lab Clinical Evaluation with Robotics, Centre of Assistive Robotics and Rehabilitation for Longevity
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
Tel 0562462311
Email 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 愛燦会(愛知県)、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
2020 Year 01 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://doi.org/10.1111/ggi.14113
Number of participants that the trial has enrolled 20
Results Focusing on a transfer support robot Hug, we selected facilities that are familiar with it or not familiar with it. As a result, there are pros and cons to the usability of the robot, and the time for transfer assistance was extended after the introduction, but reduced to half in a month with a proficiency effect. The number of calls increased with the use of robot, which may help to increase communication from caregivers to the recipients.
Results date posted
2021 Year 01 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 12 Month 16 Day
Baseline Characteristics Caregiver 15, Care recipient 5
Participant flow
Adverse events Non
Outcome measures Physical and psychological burden of care workers
Changes in time required for nursing care as devices become more proficient
Plan to share IPD Non
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 07 Month 22 Day
Date of IRB
2019 Year 07 Month 29 Day
Anticipated trial start date
2019 Year 08 Month 05 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 01 Month 20 Day
Last modified on
2021 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044708

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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