UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063375 |
|---|---|
| Receipt number | R000072546 |
| Scientific Title | Development and Evaluation of a Program to Enhance Nursing Students' Dementia Communication Skills Using Dialogue with a Dementia AI Avatar and AI-Generated Summaries |
| Date of disclosure of the study information | 2026/10/22 |
| Last modified on | 2026/10/22 15:24:21 |
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Basic information
Public title
Development of a Program to Enhance Nursing Students' Dementia Communication Skills Using Dialogue with an AI Avatar and AI-Generated Summaries
Acronym
Communication Training for Nursing Students Using a Dementia AI Avatar and AI-Generated Summaries
Scientific Title
Development and Evaluation of a Program to Enhance Nursing Students' Dementia Communication Skills Using Dialogue with a Dementia AI Avatar and AI-Generated Summaries
Scientific Title:Acronym
Dementia Communication Training Using an AI Avatar and AI-Generated Summaries
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an interactive simulation-based learning program using a dementia AI avatar and AI-generated summaries for nursing students with limited experience interacting with older adults with dementia, and to evaluate its effectiveness.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in nursing students' speech behaviors toward people with dementia before and after the interactive simulation using an AI avatar.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use of Dialogue with a Dementia AI Avatar and AI-Generated Summaries
Interventions/Control_2
Role-play among students and viewing of educational videos
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- First- and second-year university students who agree to participate in the study.
- Aged 18 to under 25 years.
Key exclusion criteria
None
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Mio |
| Middle name | |
| Last name | Ito |
Organization
Kansai Medical University
Division name
Graduate School of Nursing
Zip code
573-1004
Address
2-2-2, Shinmachi, Hirakata-city, Osaka
TEL
81-72-804-0178
itou.mio@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Mio |
| Middle name | |
| Last name | Ito |
Organization
Kansai Medical University
Division name
Graduate School of Nursing
Zip code
572-1004
Address
2-2-2, Shinmachi, Hirakata-city, Osaka
TEL
81-72-804-0178
Homepage URL
itou.mio@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-2-2, Shinmachi, HIrakata-city, Osaka
Tel
81-72-804-2440
rinri@kmu.ac.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
関西医科大学看護学部
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 22 | 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 | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2027 | 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 | 10 | Month | 22 | Day |
Last modified on
| 2026 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072546
