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
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
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
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
