UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060267 |
|---|---|
| Receipt number | R000068937 |
| Scientific Title | Development of an AI-Based Practicum Support Agent for Nursing Students: A Single-Group Intervention Study |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/06 11:22:12 |
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Basic information
Public title
Development of an AI-Based Practicum Support Agent for Nursing Students: A Single-Group Intervention Study
Acronym
Single-Arm NAIS Trial(Nursing-AI Support)
Scientific Title
Development of an AI-Based Practicum Support Agent for Nursing Students: A Single-Group Intervention Study
Scientific Title:Acronym
Single-Arm NAIS Trial(Nursing-AI Support)
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to clarify the feasibility of a generative AI-based autonomous support agent in clinical practicum settings designed to assist nursing students by addressing their difficulties and questions during the practicum experience.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Application Operation Information: Uptime Rate
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
A web-based AI agent that provides autonomous, generative AI-driven support to nursing students during clinical practicum to address their difficulties and questions.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Undergraduate students enrolled in a nursing program
Scheduled to participate in a clinical practicum in the domain where the AI model was developed
Provided written informed consent after understanding the purpose and content of the study
Key exclusion criteria
Students who do not have sufficient access to devices (e.g., PC or tablet) during the practicum period
Students who are deemed unable to participate continuously due to illness or other circumstances
Students who withdraw their consent to participate in the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Asahiko |
| Middle name | |
| Last name | Higashitsuji |
Organization
Chiba prefectural university of health sciences
Division name
Faculty of Healthcare Sciences
Zip code
2610014
Address
2-10-1 Wakaba, Mihama-ku, Chiba City
TEL
0432722000
asahiko-nursingres@umin.ac.jp
Public contact
Name of contact person
| 1st name | Asahiko |
| Middle name | |
| Last name | Higashitsuji |
Organization
Chiba prefectural university of health sciences
Division name
Faculty of Healthcare Sciences
Zip code
2610014
Address
2-10-1 Wakaba, Mihama-ku, Chiba City
TEL
0432722000
Homepage URL
asahiko-nursingres@umin.ac.jp
Sponsor or person
Institute
Chiba prefectural university of health sciences
Institute
Department
Personal name
Asahiko Higashitsuji
Funding Source
Organization
Chiba prefectural university of health sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Chiba Prefectural University of Health Sciences
Address
2-10-1 Wakaba, Mihama-ku, Chiba City
Tel
043-296-2000
cpuhs1@mz.pref.chiba.lg.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
千葉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068937
