Hand HygieneNCT06211660
An Edge AI-based AR System for Hand Hygiene Training in Undergraduates of Health Related Disciplines
A study testing AI-based AR training system and Hand scanner and Video training in people with Hand Hygiene, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- AI-based AR training system and Hand scanner and Video training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Jun 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All undergraduate students who are taking subjects in School of Nursing, School of Optometry, and Department of Applied Biology and Chemical Technology
Who cannot join
- Students with severe eczema or other extreme hand conditions will be excluded
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The School of Nursing, PolyU
Hong Kong, HK
Dr. Yang, 85227666398, l.yang@polyu.edu.hk
About this study
Official title: An AI-based AR System for Hand Hygiene Training in Undergraduates of Health Related Disciplines: a Randomized Controlled Trial
The goal of this study is to design and test an innovative education tool for hand hygiene. The main aims are:
- develop a prototype of the AI-empowered AR system for hand hygiene training and assessment in undergraduates of health-related disciplines;
- 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;
- 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.
Read the detailed 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:
- develop a prototype of the AI-empowered AR system for hand hygiene training and assessment in undergraduates of health-related disciplines;
- 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;
- 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.
- Conditions
- Hand Hygiene
- Being tested
- AI-based AR training system, Hand scanner and Video training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based AR training systemBehavioural
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.
Hand scanner and Video trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-based AR training system | Experimental | The AI-empowered AR training system will be used. Receives: Behavioral: AI-based AR training system |
| Hand scanner and Video training | Experimental | Both hand scanner results and a training video will be provided. Receives: Behavioral: Hand scanner and Video training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes after hand washing
Secondary outcomes (1)
Knowledge of hand hygiene
Participants will be asked to fill in the pre- and post questionnaires on knowledge and practice of hand hygiene as part of intervention assessment.
Measured: 10 minutes before and 10 minutes after hand washing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start25 Jun 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr YANG Lin, The Hong Kong Polytechnic University
- Investigators
- Lin Yang, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211660
- Sponsor's protocol ID
- HSEARS20231220001
- Status last verified
- May 2024
- First submitted
- 9 Jan 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared upon request to the PI.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An AI-based AR System for Hand Hygiene Training in Undergraduates of Health Related Disciplines: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06211660
- Acronym / sponsor ID
- HSEARS20231220001
- Conditions
- Hand Hygiene
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to design and test an innovative education tool for hand hygiene. The main aims are:
- develop a prototype of the AI-empowered AR system for hand hygiene training and assessment in undergraduates of health-related disciplines;
- 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;
- 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.
Detailed 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:
- develop a prototype of the AI-empowered AR system for hand hygiene training and assessment in undergraduates of health-related disciplines;
- 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;
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-based AR training system | Experimental | Behavioral: AI-based AR training systemThe AI-empowered AR training system will be used. |
| Hand scanner and Video training | Experimental | Behavioral: Hand scanner and Video trainingBoth hand scanner results and a training video will be provided. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All undergraduate students who are taking subjects in School of Nursing, School of Optometry, and Department of Applied Biology and Chemical Technology
Key exclusion criteria (1 listed)
- Students with severe eczema or other extreme hand conditions will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based AR training systemParticipants 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. | Behavioural | AI-based AR training system |
| Hand scanner and Video trainingParticipants 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. | Behavioural | Hand scanner and Video training |
Primary outcome
Practice of hand hygiene
Time frame: 5 minutes after hand washing
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.
1 secondary outcome
Knowledge of hand hygiene
Time frame: 10 minutes before and 10 minutes after hand washing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: Yes. All IPD will be shared upon request to the PI.
Related trials for Hand Hygiene
Not yet recruiting
Effect of Digital Method-Based Hand Hygiene Education on Handwashing Skills in Primary School Students
Hand Hygiene, School Health, Primary School Students, Health Education
Recruiting
Tailor VHA HH Bundle for Acute Mental Health Care
Hand Hygiene Compliance
Not yet recruitingObservational study
Hand Hygiene Compliance and Bacterial Colonization on Personal Belongings
Intensive Care Nurses, Bacterial Colonization
Not yet recruiting
Fluorescent Hand Hygiene Training and Long-Term Effects in First-Year Nursing Students
Hand Hygiene Compliance, Hand Hygiene Effectiveness
Recruiting
Effectiveness of VR on the Sustainability of Hand Hygiene Compliance: School-based RCT With 10-month Follow-up
Hand, Hygiene Practices and Knowledge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Yang, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based AR training system and Hand scanner and Video training in people with Hand Hygiene, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Yang, PhD (852-27666398, l.yang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Practice of hand hygiene (time frame: 5 minutes after hand washing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.