NCT06972043

Brief Summary

To address workforce shortages and increasing workloads in nursing, technological solutions and AI-powered robots for ward navigation have been introduced. However, limitations remain in their application to clinical care. This study aims to develop and test a programming framework for an AI-assisted nursing care robot ("E-Nursing Assistant") to reduce nurses' workload and improve the efficiency and quality of care.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
Last Updated

May 14, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 7, 2025

Last Update Submit

May 6, 2025

Conditions

Keywords

NursingArtificial Intelligence (AI)Medical Science and Technology

Outcome Measures

Primary Outcomes (1)

  • Workload-related stress in nursing staff

    The investigators utilized the Nurse Stress Checklist Chinese version translated by Taiwanese scholars in 1996. The scale consists of four factors: "Personal Response," "Work Concerns," "Job Competence," and "Inability to Complete Personal Tasks." It contains a total of 43 items, each rated on a 9-point Likert scale (0 = not at all, 1 = not close, 8 = very close), with higher scores indicating greater levels of work-related stress.

    It will be measured pre-intervention and immediately after the intervention.

Secondary Outcomes (2)

  • System Usability

    It will be measured immediately after the intervention.

  • Number of patients served and time spent on various nursing tasks

    It will be measured pre-intervention and during the intervention

Study Arms (1)

Intervention Group

OTHER

The functions performed by the robot include guiding patients through unit-specific locations for environmental orientation and equipment usage instructions, playing educational videos related to care, reminding patients of important examination precautions, providing health education on specimen collection, and delivering responses through an expert-developed medical Q\&A system.

Other: Intervention Group

Interventions

The functions performed by the robot include guiding patients through unit-specific locations for environmental orientation and equipment usage instructions, playing educational videos related to care, reminding patients of important examination precautions, providing health education on specimen collection, and delivering responses through an expert-developed medical Q\&A system.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older.
  • Currently employed as a ward nurse.

You may not qualify if:

  • Nurses who do not actively participate in ward care, such as nursing unit supervisors.
  • Patients/Caregivers
  • Aged 18 years or older.
  • Willing to accept the "E-Nursing Assistant" intervention for care tasks that do not involve patient safety.
  • Patients or caregivers who are unconscious or unable to communicate verbally or in writing to complete the research interview.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 802, Taiwan

RECRUITING

Central Study Contacts

Yun-Hsiang Lee Associate Professor, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Since the robot will interact with patients or caregivers during its operation in the ward, in addition to the nursing staff completing the informed consent form, patients or caregivers will also be required to fill out a consent form.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

May 14, 2025

Study Start

April 30, 2025

Primary Completion

December 31, 2025

Study Completion

March 27, 2026

Last Updated

May 14, 2025

Record last verified: 2025-04

Locations