Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05872581 |
| Other study ID # |
HSEARS20230103002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
The Hong Kong Polytechnic University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
