- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06972043
- Original Trial
AI-Assisted Smart Interactive Healthcare Robot
September 9, 2026 updated by: National Taiwan University Hospital
Development and Testing of an AI-Assisted Smart Interactive Healthcare Robot Program
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
In response to the challenges of workforce shortages and heavy workloads in the nursing field, clinical nursing practices are gradually integrating technological assistance, including the use of mobile phones to scan QR codes for viewing instructional videos and the introduction of robots with Artificial Intelligence (AI) technology for ward navigation.
However, there are still several limitations to these technological applications in the nursing care process.
Therefore, this study aims to develop and test the programming framework for an AI-assisted nursing care robot ("E-Nursing Assistant").
The goal is to reduce the workload of nursing staff and significantly improve the efficiency and quality of nursing work.
The "E-Nursing Assistant" will be implemented in the ward to measure the nursing staff's workload, the time and frequency spent on specific nursing tasks, and to conduct interviews to gather their feedback.
Study Type
Interventional
Enrollment (Estimated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yun-Hsiang Lee Associate Professor, PhD
- Phone Number: 288424 +886 978082338
- Email: yhlee338@ntu.edu.tw
Study Locations
-
-
Taiwan
-
Taipei, Taiwan, Taiwan, 802
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Yun Hsiang Lee Associate Professor, PhD
- Phone Number: +886 978082338
- Email: yhlee338@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Nurse
Inclusion Criteria:
- Aged 18 years or older.
- Currently employed as a ward nurse.
Exclusion Criteria:
- Nurses who do not actively participate in ward care, such as nursing unit supervisors.
- Patients/Caregivers
Inclusion Criteria:
- Aged 18 years or older.
- Willing to accept the "E-Nursing Assistant" intervention for care tasks that do not involve patient safety.
Exclusion Criteria:
- Patients or caregivers who are unconscious or unable to communicate verbally or in writing to complete the research interview.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Workload-related stress in nursing staff
Time Frame: It will be measured pre-intervention and immediately after the intervention.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability
Time Frame: It will be measured immediately after the intervention.
|
The investigators used the System Usability Scale (SUS) developed by scholar Brooke.
The scale consists of 10 items, scored on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
Odd-numbered items are positively worded, and the raw score for each item is subtracted by 1 to obtain the item score.
Even-numbered items are reverse scored, with the item score calculated as 5 minus the raw score.
The scores for all items are summed, and the total is then multiplied by 2.5 to obtain the overall SUS score, which ranges from 0 to 100.
Higher scores indicate greater satisfaction with the system.
|
It will be measured immediately after the intervention.
|
|
Number of patients served and time spent on various nursing tasks
Time Frame: It will be measured pre-intervention and during the intervention
|
A self-designed table will be used to list common and repetitive nursing tasks in the ward in detail.
These tasks include: ward orientation (e.g., nursing station), instructions for using ward equipment (e.g., patient beds, call bells), patient fall prevention education, reminders for various examinations (e.g., urination), health education for specimen collection (e.g., blood, urine), discharge instructions, and answering common questions from patients after viewing nursing care instructional videos.
Each task will include spaces to record the number of patients served and time spent.
Initially, an audio recorder will be used to measure the time, after which the researchers will calculate the start and end times, as well as any interruptions during the process, and fill in the table accordingly.
|
It will be measured pre-intervention and during the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
May 6, 2025
First Posted (Actual)
May 14, 2025
Study Record Updates
Last Update Posted (Actual)
September 14, 2026
Last Update Submitted That Met QC Criteria
September 9, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 202410046RINE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.