UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062658 |
|---|---|
| Receipt number | R000071726 |
| Scientific Title | Development of an Interactive AI Educational Support System for People with Dementia to Support the Practice of Person-Centered Care |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/22 16:31:59 |
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Basic information
Public title
Development of an Interactive AI Educational Support System for People with Dementia to Support the Practice of Person-Centered Care
Acronym
Development of an Interactive AI Educational Support System for People with Dementia
Scientific Title
Development of an Interactive AI Educational Support System for People with Dementia to Support the Practice of Person-Centered Care
Scientific Title:Acronym
Development of an Interactive AI Educational Support System for People with Dementia to Support the Practice of Person-Centered Care
Region
| Japan |
Condition
Condition
no
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, with the aim of improving nursing practice competencies related to person-centered care, changing attitudes to minimize physical restraints, and preventing falls, we will develop an interactive AI educational support system (Interactive AI Educational Support System for Patients with Dementia) that is based on dialogue with patients with dementia and prioritizes the perspectives of older adults with dementia to support the practice of person-centered care. We will then evaluate the effectiveness of this system.
Translated with DeepL.com (free version)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Demographic characteristics of study participants
2 Self-assessment of nursing practice related to dementia and expertise in the treatment and care of older adults with dementia3 Self-assessment scale (19 items) for person-centered care practices for older adults with cognitive impairment in acute-care hospitals
4. Approaches to Dementia Questionnaire (ADQ)
5. Fall Prevention Behavior Assessment Scale, designed with the avoidance of physical restraints and assistance
6.Effectiveness of the program content
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
In the AI educational system, participants learn using four case studies. After reaching a certain achievement standard completion rate) in each case study, they proceed to the next one. Upon completing all case studies, they acquire specialized knowledge in nursing practice based on person-centered care.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This study involves approximately 180 full-time nurses working in departments with a high number of elderly patients with dementia at JA Shizuoka Koseiren Shizuoka Kosei Hospital (265 beds: 130 general care beds [7:1], 40 community-based integrated care beds [13:1], and 95 post-acute care beds [13:1]).
Key exclusion criteria
Part-time nurses
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mizue |
| Middle name | |
| Last name | suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Nursing Course
Zip code
4228021
Address
1-2-1 Handa-yama, Chuo Ward, Hamamatsu City
TEL
09081898314
mizuesuzuki@gmail.com
Public contact
Name of contact person
| 1st name | Mizue |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu City, Hamamatsu Medical University
Division name
Department of Clinical Nursing
Zip code
4228021
Address
1-2-1 Handa-yama, Chuo-ku, Hamamatsu City, Hamamatsu
TEL
09081898314
Homepage URL
mizuesuzuki@gmail.com
Sponsor or person
Institute
Hamamatsu Medical University
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Medical University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Medical University
Address
1-2-1 Handa-yama, Chuo-ku, Hamamatsu City, Hamamatsu
Tel
09081898314
mizuesuzuki@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
26-128
Org. issuing International ID_1
Hamamatsu Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 22 | Day |
Last modified on
| 2026 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071726
