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

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

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


Email

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

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 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
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name