UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042385
Receipt number R000048382
Scientific Title Verification of the effects of introducing toileting support equipment to improve long-term care efficiency and support independence
Date of disclosure of the study information 2020/11/10
Last modified on 2024/03/08 12:39:05

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Basic information

Public title

Verification of the effects of introducing toileting support equipment to improve long-term care efficiency and support independence

Acronym

Verification of long-term care efficiency and independence effect by toileting support robot

Scientific Title

Verification of the effects of introducing toileting support equipment to improve long-term care efficiency and support independence

Scientific Title:Acronym

Verification of long-term care efficiency and independence effect by toileting 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 long-term care efficiency and independence effect by toileting support robot

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of independent excretion of the care recipient during 4 weeks after the start of using the toileting support robot

Key secondary outcomes

Sleep time and quality of the care recipient


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

Before introduction of toileting support robot

Interventions/Control_2

After introduction of toileting support robot (4 weeks use)

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. Up to 20 long-term care workers in facilities that are familiar with a toileting support robots, up to 20 long-term care workers in facilities that are not familiar with them, also up to 20 nursing staff or care workers in Convalescent and Community Comprehensive Care Wards of National Center of Geriatrics and Gerontology and the care recipients (Maximum 4 people each: Up to 12 people in the above 2 facilities), who uses the support robot
2. Among them, the consent of the document was obtained with the free will of the person who participated in this study.

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

72


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

Center 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 Center for Geriatrics and Gerontology

Division name

Lab Clinical Evaluation with Robotics, Center 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 Center for Geriatrics and Gerontology, Center 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

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Geriatrics and Gerontology, Ethics and Conflicts of Interest Committee

Address

7-430, Morioka, Obu, Aichi 474-8511, JAPAN

Tel

+81-562-462311

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

特別養護老人ホーム 岐阜県立寿楽苑(岐阜県)、特別養護老人ホーム ドリーム陶都(岐阜県)、国立研究開発法人 国立長寿医療研究センター 回復期リハビリテーション病棟・地域包括ケア病棟(愛知県)


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 10 Day


Related information

URL releasing protocol

https://www.ncgg.go.jp/ri/topics/pamph/documents/haisetsu.pdf

Publication of results

Published


Result

URL related to results and publications

https://www.ncgg.go.jp/ri/topics/pamph/documents/haisetsu.pdf

Number of participants that the trial has enrolled

20

Results

We introduced two flush portable toilets (Kyuretto) and two wrap-type portable toilets, which are excretion support robot care devices, into a nursing facility, and conducted demonstrations focusing on independence support in excretion care for four care recipients. Although no improvement in sleep was observed, a reduction in the amount of odorants was confirmed. As a result, the quality of nursing care has improved, and implementation at home may be considered.

Results date posted

2024 Year 03 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 03 Month 26 Day

Baseline Characteristics

Nursing home residents and their caregivers

Participant flow

We asked care facilities to recommend suitable care recipients (who can use bedside toilets) and installed the equipment for intervention purposes. The caregivers responsible for their care were asked to participate in the study, and their consent was obtained.

Adverse events

Non

Outcome measures

User's independent defecation frequency
Sleep time, sleep quality

Plan to share IPD

By individual inquiry

IPD sharing Plan description

We will only provide information about the research if we deem it appropriate.


Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 09 Month 09 Day

Date of IRB

2020 Year 10 Month 12 Day

Anticipated trial start date

2020 Year 10 Month 15 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 11 Month 09 Day

Last modified on

2024 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name