Hand HygieneNCT05872581
Education Program of Hand Hygiene for Nursing Students
A study testing Hand scanner instant feedback 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 observational study is to design and test a multicomponent education program of hand hygiene in nursing students. The main aims are: 1. conduct a randomized controlled trial (RCT) to test the effectiveness of this program on knowledge and practice of hand hygiene in nursing students; 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?
- Hand scanner instant feedback and Video training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2023to 31 Jul 2023
- 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 year one nursing students from the Bachelor of Nursing and Bachelor of Mental Health Nursing program in School of Nursing
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
The Squina International Centre for Infection Control, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: The Effectiveness of a Multicomponent Education Program of Hand Hygiene in Nursing Students: a Randomized Controlled Trial
The goal of this observational study is to design and test a multicomponent education program of hand hygiene in nursing students. The main aims are:
- conduct a randomized controlled trial (RCT) to test the effectiveness of this program on knowledge and practice of hand hygiene in nursing students;
- evaluate the effects of each component and collect feedbacks from participants.
Participants will be randomly assigned into the three intervention: Group A (Hand scanner instant feedback) , Group B (Video training), Group C (Hand scanner + Video training) , and Group D (Control group without intervention). 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 500000 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 nursing students 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 education program. This study aims to design and test a multicomponent education program of hand hygiene in nursing students. Specifically, this program has two components: 1) training videos according to the WHO guidelines on hand hygiene in health care; 2) a hand scanner used for students to immediately visualize the missing spots of hand hygiene.
If demonstrated effective, this program can be integrated into the curriculum of nursing students 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.
Subject recruitment
The investigators will recruit all year one nursing students from the Bachelor of Nursing and Bachelor of Mental Health Nursing program in School of Nursing (total number is approximately 320). The participants will subscribe a timeslot of training sessions. 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 investigators calculated the statistical power for cluster randomized controlled trial. Since the total number is fixed to 320 and each cluster has 4 participants, there will be a total of 80 clusters which are equally divided into four groups. It is assumed that the standard deviation of subjects is 2.00, the intracluster correlation coefficient is 0.010, and the coefficient of variation of cluster sizes is 0.500. The sample size of 320 can achieve 87% power to detect a difference between the group means of at least 1 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 hand washing 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.
Post-intervention assessment
The participants will take the second hand washing 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.
For the training purpose, after the completion of post-intervention measurements, the participants of the control group will watch the training video and repeated hand washing and scanning for the third time if they agree. But the results of their third hand washing attempt will not be included into data analysis in this study.
Randomization, allocation concealment, and blinding
Participants will be randomly assigned to the intervention groups or control group 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
- Hand scanner instant feedback, Video training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand scanner instant feedbackBehavioural
Participants will be informed about their hand scanner results of the first hand washing attempt to get individualized feedback about their hand wash performance.
Video trainingBehavioural
Participants will watch a training video about the 7 steps of hand washing after the first hand washing attempt.
| Study group | Role | What they receive |
|---|---|---|
| Hand scanner instant feedback | Experimental | Hand scanner results only but no training videos will be provided. Receives: Behavioral: Hand scanner instant feedback |
| Video training | Experimental | A training video only but no hand scanner results will be provided. Receives: Behavioral: Video training |
| Hand scanner and Video training | Experimental | Both hand scanner results and a training video will be provided. Receives: Behavioral: Hand scanner instant feedback; Behavioral: Video training |
| Control group without intervention | No intervention | No hand scanner results or training videos will be provided. |
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 posted24 May 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- 280 participants (actual)
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
- NCT05872581
- Sponsor's protocol ID
- HSEARS20230103002
- Status last verified
- Sep 2023
- First submitted
- 25 Apr 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared upon request to the PI.
Publications
Chen J, Yang L, Mak YW, O'Donoghue M, Shi C, Tsang H, Lu S, Zou J, Qin J, Xie YJ, Lai T, Li C, Cao J, Pittet D. Hand Hygiene Education Components Among First-Year Nursing Students: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2413835. doi: 10.1001/jamanetworkopen.2024.13835.
PubMed 38869902
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Multicomponent Education Program of Hand Hygiene in Nursing Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05872581
- Acronym / sponsor ID
- HSEARS20230103002
- Conditions
- Hand Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 May 2023 (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 observational study is to design and test a multicomponent education program of hand hygiene in nursing students. The main aims are:
- conduct a randomized controlled trial (RCT) to test the effectiveness of this program on knowledge and practice of hand hygiene in nursing students;
- evaluate the effects of each component and collect feedbacks from participants.
Participants will be randomly assigned into the three intervention: Group A (Hand scanner instant feedback) , Group B (Video training), Group C (Hand scanner + Video training) , and Group D (Control group without intervention). 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 500000 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 nursing students 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 education program. This study aims to design and test a multicomponent education program of hand hygiene in nursing students. Specifically, this program has two components: 1) training videos according to the WHO guidelines on hand hygiene in health care; 2) a hand scanner used for students to immediately visualize the missing spots of hand hygiene.
If demonstrated effective, this program can be integrated into the curriculum of nursing students 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.
Subject recruitment
The investigators will recruit all year one nursing students from the Bachelor of Nursing and Bachelor of Mental Health Nursing program in School of Nursing (total number is approximately 320). The participants will subscribe a timeslot of training sessions. 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 investigators calculated the statistical power for cluster randomized controlled trial. Since the total number is fixed to 320 and each cluster has 4 participants, there will be a total of 80 clusters which are equally divided into four groups. It is assumed that the standard deviation of subjects is 2.00, the intracluster correlation coefficient is 0.010, and the coefficient of variation of cluster sizes is 0.500. The sample size of 320 can achieve 87% power to detect a difference between the group means of at least 1 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 hand washing 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.
Post-intervention assessment
The participants will take the second hand washing 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.
For the training purpose, after the completion of post-intervention measurements, the participants of the control group will watch the training video and repeated hand washing and scanning for the third time if they agree. But the results of their third hand washing attempt will not be included into data analysis in this study.
Randomization, allocation concealment, and blinding
Participants will be randomly assigned to the intervention groups or control group 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Hand scanner instant feedback | Experimental | Behavioral: Hand scanner instant feedbackHand scanner results only but no training videos will be provided. |
| Video training | Experimental | Behavioral: Video trainingA training video only but no hand scanner results will be provided. |
| Hand scanner and Video training | Experimental | Behavioral: Hand scanner instant feedback, Behavioral: Video trainingBoth hand scanner results and a training video will be provided. |
| Control group without intervention | No intervention | –No hand scanner results or training videos will be provided. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all year one nursing students from the Bachelor of Nursing and Bachelor of Mental Health Nursing program in School of Nursing
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 |
|---|---|---|
| Hand scanner instant feedbackParticipants will be informed about their hand scanner results of the first hand washing attempt to get individualized feedback about their hand wash performance. | Behavioural | Hand scanner and Video training, Hand scanner instant feedback |
| Video trainingParticipants will watch a training video about the 7 steps of hand washing after the first hand washing attempt. | Behavioural | Hand scanner and Video training, 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 38869902Chen J, Yang L, Mak YW, O'Donoghue M, Shi C, Tsang H, Lu S, Zou J, Qin J, Xie YJ, Lai T, Li C, Cao J, Pittet D. Hand Hygiene Education Components Among First-Year Nursing Students: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2413835. doi: 10.1001/jamanetworkopen.2024.13835.
- Individual participant dataSharing planned: Yes. All IPD will be shared upon request to the PI.
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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 Hand scanner instant feedback 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: finished, as of the sponsor's last update on 21 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT05872581, which also lists 1 linked publication.
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 21 Sep 2023.