UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063324 |
|---|---|
| Receipt number | R000072482 |
| Scientific Title | Effectiveness of a Generative AI-Based Clinical Documentation Support Tool for Nursing Students: A Randomized Controlled Trial in Clinical Practicum Settings |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/17 05:05:01 |
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Basic information
Public title
Effectiveness of a Generative AI-Based Clinical Documentation Support Tool for Nursing Students: A Randomized Controlled Trial in Clinical Practicum Settings
Acronym
GenAI-NCP Trial (Generative AI for Nursing Clinical Practicum)
Scientific Title
Effectiveness of a Generative AI-Based Clinical Documentation Support Tool for Nursing Students: A Randomized Controlled Trial in Clinical Practicum Settings
Scientific Title:Acronym
NAIS Trial - RCT
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility and challenges of a generative artificial intelligence (AI)-based clinical documentation support tool that provides autonomous guidance to assist nursing students in addressing difficulties and questions encountered during clinical practicums.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group difference in post-practicum Clinical Reasoning Skills Self-Evaluation Scale scores, adjusted for baseline scores.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: Access to a generative AI-based clinical documentation support web application during the clinical practicum.
Interventions/Control_2
Control group: Usual clinical practicum without access to the AI-based documentation support application.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adult third- or fourth-year nursing students enrolled in a clinical practicum at the study university.
2. Students who voluntarily provide informed consent to participate in the study.
3. Students who agree to random assignment to either the intervention or control group.
Key exclusion criteria
1. Students who do not consent to study participation or random assignment.
2. Students who are unable to understand the study information or provide voluntary informed consent.
3. Students who are unable to complete the pre- and post-practicum assessments, use a study ID, or participate in the required study procedures.
4. Students who have previously participated in this trial.
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
0432962000
cpuhs1@mz.pref.chiba.lg.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
0432962000
Homepage URL
cpuhs1@mz.pref.chiba.lg.jp
Sponsor or person
Institute
Chiba prefectural university of health sciences
Institute
Department
Personal name
Funding Source
Organization
Chiba prefectural university of health sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
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
0432962000
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 19 | 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
| 2026 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 05 | 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 | 17 | Day |
Last modified on
| 2026 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072482
