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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in 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:

  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. 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 groups in NCT05872581
Study groupRoleWhat they receive
Hand scanner instant feedbackExperimentalHand scanner results only but no training videos will be provided.
Receives: Behavioral: Hand scanner instant feedback
Video trainingExperimentalA training video only but no hand scanner results will be provided.
Receives: Behavioral: Video training
Hand scanner and Video trainingExperimentalBoth hand scanner results and a training video will be provided.
Receives: Behavioral: Hand scanner instant feedback; Behavioral: Video training
Control group without interventionNo interventionNo 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.

  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.

    Measured: 5 minutes after hand washing

Secondary outcomes (1)
  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.

  1. First posted24 May 2023
  2. Study start1 Jun 2023
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Resources

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)
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

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.

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