UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044715 |
|---|---|
| Receipt number | R000051059 |
| Scientific Title | Development and implementation of AI / IoT services for dementia that reduce the burden of long-term care by predicting and preventing BPSD: Empirical study of introduction effect by RCT |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2023/01/12 12:30:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of the effects of the Dementia Care-assist AI (DeCaAI), which use sensor data and care record data, in group homes for people with dementia.
Acronym
Verification of the effectiveness of dementia care assist AI.
Scientific Title
Development and implementation of AI / IoT services for dementia that reduce the burden of long-term care by predicting and preventing BPSD: Empirical study of introduction effect by RCT
Scientific Title:Acronym
Empirical RCT study on effects of the Dementia Care-assist AI.
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this empirical RCT research, effectiveness of the Dementia Care-assist AI (DeCaAI), which predicts BPSD from the care data (vital signs such as pulse, activity, sleep, environmental information such as temperature and humidity, and nursing care records) and propose optimal care to care staff, will be studied.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The person with dementia : Severity of BPSD
Care worker : Time study
Key secondary outcomes
The person with dementia : QOL, ADL
Care worker : Burden of BPSD, QOL
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Introduction of vital sensors, environmental sensors, and hearable devices for care records. The AI analyzes predict BPSD from the care data, and simultaneously proposes optimal care to the staff. Care worker will practice this intervention for 3 months.
Interventions/Control_2
Continue conventional care for 3 months as a control group without using the above sensors and devices.
Interventions/Control_3
After the completion of intervention 1, optimal care is not proposed from AI, and the care worker practices care without the BPSD prediction function for 3 months.
Interventions/Control_4
After the completion of Intervention 2, a sensor and device different from Intervention 1 will be introduced, AI predicts BPSD and proposes optimal care. Care workers will practice it for 3 months.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Have dementia and be able to speak.
Key exclusion criteria
1) Rank C (bedridden) is excluded from the degree of independence in daily life of the elderly with disabilities.
2) Tube feeding is excluded.
3) Excludes those for which consent cannot be obtained.
4) Even after the start of measurement, if a new disease occurs or if the activity level has dropped sharply in the subject, it is excluded from the study.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Haruyasu |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tokyo Center for Dementia Care Research and Practice in Tokyo
Division name
Research department
Zip code
168-0071
Address
1-12-1, Takaidonishi, Suginamiku, Tokyo, Japan
TEL
03-3334-2173
yamaguti@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Okonogi |
Organization
Tokyo Center for Dementia Care Research and Practice in Tokyo
Division name
Research department
Zip code
168-0071
Address
1-12-1, Takaidonishi, Suginamiku, Tokyo, Japan
TEL
03-3334-2173
Homepage URL
ai-care-amed@dcnet.gr.jp
Sponsor or person
Institute
Tokyo Center for Dementia Care Research and Practice in Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Senior Dementia Institute
The University of Electro-Communications
National Institute of Advanced Industrial Science and Technology
University of Hyogo
International University of Health and Welfare
Saitama Prefectural University
Gunma University
National Center for Geriatrics and Gerontology
Nihon Fukushi University
Allm Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Center for Dementia Care Research and Practice in Tokyo Institutional Review Board
Address
1-12-1, Takaidonishi, Suginamiku, Tokyo, Japan
Tel
03-6743-2181
tokyo_dcrc@dcnet.gr.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051059
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
