UMIN-ICDS Clinical Trial

Public title

A study of the effects of guideline-referenced AI use among home-visit nurses

Acronym

Home-Visit Nurse AI Use Study

Scientific Title

Web-Based Comparative Study of the Effects of Guideline-Referenced AI Use Among Home-Visit Nurses

Scientific Title:Acronym

Home-Visit Nurse AI Web Comparative Study

Region

Japan

Condition

Not applicable; web-based simulated case task among home-visit nurses

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to examine the effects of guideline-referenced AI use on perceived mental effort, perceived task difficulty, and confidence after completing a simulated case-based task among home-visit nurses.

Basic objectives2

Others

Basic objectives -Others

Educational, behavioural, or informational support

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Perceived mental effort assessed immediately after completing the task using a 9-point single-item rating. Scores range from 1 to 9, with higher scores indicating greater mental effort invested in completing the task.

Key secondary outcomes

Perceived task difficulty and confidence in the correctness of the final answer, each assessed immediately after completing the task using a 9-point single-item rating. Scores range from 1 to 9, with higher scores indicating greater perceived task difficulty or greater confidence in the final answer.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

AI group: Participants completed a simulated home-visit nursing case task involving an older adult living alone with chronic heart failure. During the task, they were allowed to use a guideline-referenced AI chat system built with NotebookLM. The system was preloaded with publicly available heart failure-related clinical guidelines and allowed participants to ask questions in natural language and refer to the generated responses. The task was completed once online. Participants were instructed not to refer to external information sources other than the AI system during the task.

Interventions/Control_2

Non-AI group: Participants completed the same simulated home-visit nursing case task once online without access to the guideline-referenced AI chat system. They were instructed not to refer to external information sources during the task.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Nurses currently engaged in home-visit nursing practice in Japan
2. Individuals able to read the study information and respond to the questionnaire in Japanese
3. Individuals with access to a web-enabled device for completing the task and questionnaire
4. Individuals who provided informed consent through the web-based form

Key exclusion criteria

1. Participants who did not complete the task after providing consent
2. Participants whose responses were clearly incomplete, such as missing primary outcome data

Target sample size

172

Name of lead principal investigator

1st name	Takemasa
Middle name
Last name	Ishikawa

Organization

Tekix Corporation

Division name

Nana-r Home-visit Nursing Development Center

Zip code

560-0085

Address

#301, 3-6-17, Kamichinden, Toyonaka, Osaka, Japan

TEL

050-1871-0457

Email

info@nana-dc.jp

Name of contact person

1st name	Takemasa
Middle name
Last name	Ishikawa

Organization

Tekix Corporation

Division name

Nana-r Home-visit Nursing Development Center

Zip code

560-0085

Address

#301, 3-6-17, Kamichinden, Toyonaka, Osaka, Japan

TEL

050-1871-0457

Homepage URL

Email

ishikawa@nana-r.jp

Institute

Tekix Corporation

Institute

Department

Personal name

Organization

France Bed Home Care Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Tekix Inc. Research Ethics and Conflict of Interest Review Committee

Address

6F Otemae Rui Daiichi Building, 2-2-20 Tanimachi, Chuo-ku, Osaka, Japan

Tel

050-1871-0457

Email

info@nana-dc.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

04

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

140

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

Recruitment status

Completed

Date of protocol fixation

2026

Year

02

Month

05

Day

Date of IRB

2026

Year

03

Month

06

Day

Anticipated trial start date

2026

Year

03

Month

09

Day

Last follow-up date

2026

Year

03

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

04

Month

30

Day

Last modified on

2026

Year

04

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070275