UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061719 |
|---|---|
| Receipt number | R000070637 |
| Scientific Title | A study on the burden on care staff and the impact on the quality of life of residents during the process of becoming proficient in using multi-functional monitoring sensors. |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/28 16:24:27 |
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Basic information
Public title
A study on the burden on care staff and the impact on the quality of life of residents during the process of becoming proficient in using multi-functional monitoring sensors.
Acronym
Study on the caregivers and residents regarding the process of becoming proficient in using multi-functional monitoring sensors.
Scientific Title
A study on the burden on care staff and the impact on the quality of life of residents during the process of becoming proficient in using multi-functional monitoring sensors.
Scientific Title:Acronym
Study on the caregivers and residents regarding the process of becoming proficient in using multi-functional monitoring sensors.
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness of introducing and mastering the use of monitoring sensors in improving the work efficiency of care staff.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical and psychological burden on care workers
Key secondary outcomes
Indicators of staff behavior, operations, and acceptance, as well as indicators of users' QOL, sleep, safety, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Advice on mastering the introduction of multi-functional monitoring devices.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 105 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Caregivers: Individuals working at the nursing facility.
Residents: Elderly individuals residing in or staying at the nursing facility.
Key exclusion criteria
Residents: Individuals using bedding or equipment that is difficult to use in conjunction with monitoring sensors, such as pressure ulcer prevention mattresses, will be excluded.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kato |
Organization
National Center for Geriatrics and Gerontology
Division name
Laboratory of Clinical Evaluation with Robotics, Assistive Robot Center
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
kk0724@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yoshimi |
Organization
National Center for Geriatrics and Gerontology
Division name
Laboratory of Clinical Evaluation with Robotics, Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
Homepage URL
yoshimit@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
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
Meijo University
Fujita Health University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics and Conflict of Interest Committee, National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
Tel
0562462311
IRB@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
１． 愛厚ホーム大府苑 愛知県大府市
２． さわやかの丘 愛知県大府市
３． なごみの郷 愛知県蒲郡市
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2027 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070637
