NCT06211660

Brief Summary

The goal of this study is to design and test an innovative education tool for hand hygiene. The main aims are:

  1. 1.develop a prototype of the AI-empowered AR system for hand hygiene training and assessment in undergraduates of health-related disciplines;
  2. 2.conduct a non-inferiority randomized controlled trial (RCT) to test the effectiveness of this AI-based AR training system on knowledge and practice of hand hygiene in students of health related disciplines;
  3. 3.evaluate the effects of the AI-based AR training system and collect feedbacks from participants.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

August 30, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

January 9, 2024

Last Update Submit

August 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Practice of hand hygiene

    The percentage (from 0 to 100%, the higher scores mean a worse outcome) of fluorescent gel residual on hands shown in the hand scanner will be used as an objective assessment for efficacy of hand washing in individual participants.

    5 minutes after hand washing

Secondary Outcomes (1)

  • Knowledge of hand hygiene

    10 minutes before and 10 minutes after hand washing

Study Arms (2)

AI-based AR training system

EXPERIMENTAL

The AI-empowered AR training system will be used.

Behavioral: AI-based AR training system

Hand scanner and Video training

EXPERIMENTAL

Both hand scanner results and a training video will be provided.

Behavioral: Hand scanner and Video training

Interventions

Participants will use the AI-empowered AR training system to get individualized assessments of their hand wash performance. They will not be informed about the hand scanner results.

AI-based AR training system

Participants will use an existing education program that has been demonstrated effective in our previous study (unpublished). In brief, the participants will be informed about their hand scanner results during the first HW attempt. They will also watch a training video about the 7 steps of hand washing.

Hand scanner and Video training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All undergraduate students who are taking subjects in School of Nursing, School of Optometry, and Department of Applied Biology and Chemical Technology

You may not qualify if:

  • Students with severe eczema or other extreme hand conditions will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The School of Nursing, PolyU

Hong Kong, HK, Hong Kong

RECRUITING

Study Officials

  • Lin Yang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 18, 2024

Study Start

June 25, 2024

Primary Completion

December 30, 2024

Study Completion

March 31, 2025

Last Updated

August 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

All IPD will be shared upon request to the PI.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Starting 6 months after publication.
Access Criteria
The Responsible Party will review the requests.

Locations