- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05872581
Education Program of Hand Hygiene for Nursing Students
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Squina International Centre for Infection Control, The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- all year one nursing students from the Bachelor of Nursing and Bachelor of Mental Health Nursing program in School of Nursing
Exclusion Criteria:
- students with severe eczema or other extreme hand conditions will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hand scanner instant feedback
Hand scanner results only but no training videos will be provided.
|
Participants will be informed about their hand scanner results of the first hand washing attempt to get individualized feedback about their hand wash performance.
|
|
Experimental: Video training
A training video only but no hand scanner results will be provided.
|
Participants will watch a training video about the 7 steps of hand washing after the first hand washing attempt.
|
|
Experimental: Hand scanner and Video training
Both hand scanner results and a training video will be provided.
|
Participants will be informed about their hand scanner results of the first hand washing attempt to get individualized feedback about their hand wash performance.
Participants will watch a training video about the 7 steps of hand washing after the first hand washing attempt.
|
|
No Intervention: Control group without intervention
No hand scanner results or training videos will be provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 minutes after hand washing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of hand hygiene
Time Frame: 10 minutes before and 10 minutes after hand washing
|
Participants will be asked to fill in the pre- and post questionnaires on knowledge and practice of hand hygiene as part of intervention assessment.
|
10 minutes before and 10 minutes after hand washing
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lin Yang, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSEARS20230103002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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