Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06211660 |
| Other study ID # |
HSEARS20231220001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
The Hong Kong Polytechnic University |
| Contact |
Lin Yang, PhD |
| Phone |
852-27666398 |
| Email |
l.yang[@]polyu.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to design and test an innovative education tool for hand hygiene.
The main aims are:
1. develop a prototype of the AI-empowered AR system for hand hygiene training and
assessment in undergraduates of health-related disciplines;
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. evaluate the effects of the AI-based AR training system and collect feedbacks from
participants.
Participants will be randomly assigned into the two intervention: Group A (AI-based AR
training system) and Group B (Hand scanner and Video training). Pre- and post-intervention
assessment will be used to evaluate the effectiveness of the program and individual
components.
Description:
Background The ongoing COVID-19 pandemic has posed serious threats to public health
worldwide. Although children have mild symptoms, they have been found to more likely transmit
the virus within the household than the other age groups. The importance of hand hygiene
cannot be underestimated in both healthcare and community settings. The promotion of hand
hygiene is the best practices in preventing health care-associated infection. It has been
estimated that hand hygiene could reduce over 500 000 attributable deaths per year. It was
found that the annual economic impact of health care-associated infection in the US was
approximately US$6.5 billion in 2004 and every US$1 spent on hand hygiene promotion could
result in a US$23.7 benefit. Education plays a key role in setting a good practice base in
hand hygiene.
The traditional training methods for students of health related disciplines include in-class
lecture and practical, but students seldom receive individualized instructions and feedbacks
due to limited manpower and facilities. Hence, there is an urgent need of designing an
automated and individualized training system. This proposed project aims to design and test
an innovative education tool for hand hygiene, with the following specific objectives:
1. develop a prototype of the AI-empowered AR system for hand hygiene training and
assessment in undergraduates of health-related disciplines;
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. evaluate the effects of the AI-based AR training system and collect feedbacks from
participants.
If demonstrated effective, this system can be integrated into the curriculum of students of
health related disciplines as an e-learning approach. In future, this system can also be used
at point-of-care for real-time monitoring and audit of healthcare workers in other healthcare
settings.
Methods Study design: This is a non-inferiority two-arm RCT.
Subject recruitment Cross-discipline undergraduate students who are taking subjects in School
of Nursing, School of Optometry, and Department of Applied Biology and Chemical Technology
will be recruited during January to June 2024. The participants will subscribe a timeslot of
training sessions (each session has 4 participants). All participants who attend the same
session will be assigned to the same group by cluster randomization. A statistician will
assign the groups in advance by a random number generator. The participants will not be
informed about their group before arriving the study site (the Squina International Centre
for Infection Control in PolyU).
Sample size for a cluster randomized controlled trial Assuming that the number of participant
in each cluster ranges from 5 to 20, there will be approximately 6-20 clusters in each group.
The standard deviation of subjects is assumed to be 2.00, the intracluster correlation
coefficient is 0.010, and the coefficient of variation of cluster sizes is 0.500. The sample
size of 200-240 can achieve >91% power to detect a difference between two group means
(confidence interval -1.0 and 1.0) in a two-sided t-test with a significance level of 0.050.
Pre-intervention assessment During the site visit, the participants will sign a consent form
first and be asked to fill in a questionnaire on knowledge and practice of hand hygiene.
Participants will need to put fluorescent powder on both of their hands and then perform hand
washing using liquid soap without any instructions (1st HW attempt). The camera installed
above the hand-wash basins will take videos of both hands (no face nor other parts of the
body) during this procedure. After washing hands, participants will need to scan fluorescent
powder remained on their hands in a hand scanner (The Semmelweis Scanner™). The recorded hand
washing videos will be used to train the AI algorithms for automatic image processing and
assessments. Two IPC experts will judge the quality of hand hygiene in these videos, which
will be adopted as ground truth in image processing. The percentage 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.
Interventions groups
Group A (AI-based AR training system) 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.
Group B (Hand scanner + Video training) Participants will use an existing education program
that has been demonstrated effective in our previous study. 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.
Post-intervention assessment The participants will take the second HW attempt by putting
fluorescent powder on both of their hands again and then perform hand wash with videos
recorded. After washing hands, participants will scan fluorescent powder remained on their
hands again in a hand scanner.
Participants will also be asked to fill in a questionnaire on knowledge and practice of hand
hygiene as part of post-intervention assessment.
Randomization, allocation concealment, and blinding Participants will be randomly assigned to
the intervention groups through a process of randomization performed by a statistician who
will not be involved in subject recruitment. The participants will be blinded. The RAs
involved in subject recruitment and the IPC experts who judge the quality of hand hygiene
will be blinded to the groupings. The RAs and student assistants involved in hand hygiene
video recording at the study site will not be blinded because they will be giving
instructions to the participants.
