Effectiveness of an Edge AI-based Augmented Reality System for Hand Hygiene Training: a Multi-centre, Mixed-methods Cluster Randomised Controlled Trial

NCT07280026 | Recruiting DMC

• 1 other identifier: HSEARS20250907003
• Study Type: interventional
• Target: 1,000
• Locations: 2 countries
• Sites: 3

Brief Summary

This multi-centre, mixed-methods cluster randomised controlled trial (cRCT) aims to evaluate the effectiveness of an edge artificial intelligence (AI)-based augmented reality (AR) training and assessment system for improving hand hygiene knowledge and practice across healthcare and educational settings. Hand hygiene remains one of the most effective measures to prevent healthcare-associated infections (HAIs), which cause substantial morbidity, mortality, and economic burden worldwide. Despite ongoing education efforts, conventional training methods-such as lectures and standard videos-often lack individualised feedback and interactivity, limiting behavioural improvement. The proposed AI-empowered AR system provides real-time assessment and personalised guidance, potentially transforming hand hygiene education into an adaptive, scalable, and evidence-driven learning experience. The trial will be conducted at three centres: the Hong Kong Polytechnic University and the Chinese University of Hong Kong in Hong Kong SAR, and Tongji Hospital in Wuhan, China. Approximately 480 participants will be enrolled, including 240 undergraduate students in health-related disciplines and 240 healthcare professionals or supporting staff from hospitals. Cluster randomisation will be applied at the session level (6-25 participants per cluster). Randomisation will be performed by a statistician independent from recruitment, and allocation concealment will be maintained. The study will adopt a non-inferiority design, comparing the AI-based AR system against an existing validated educational program combining hand scanner feedback and instructional videos. Participants and assessors of handwashing quality will remain blinded to group allocation. At baseline, participants will provide written informed consent and complete a standardized questionnaire assessing hand hygiene knowledge and practice. They will apply fluorescent powder to both hands and perform an initial handwashing attempt, recorded by an overhead camera. The percentage of fluorescent residue (measured by the Semmelweis Scanner™) will serve as an objective indicator of decontamination effectiveness, while trained infection prevention and control (IPC) experts will independently assess technique quality from anonymized video recordings. These evaluations will also be used as reference data for AI algorithm development. In the intervention arm, participants will perform AI-based AR training sessions providing individualized feedback on handwashing performance. In the control arm, participants will receive feedback from the fluorescent scanner and watch a standard "seven-step" handwashing educational video. Following training, participants will repeat the handwashing procedure and post-intervention assessments, including fluorescent residue measurement and the same knowledge-practice questionnaire. The primary outcome is the improvement in decontamination effectiveness (reduction in fluorescent residue percentage between pre- and post-intervention). Secondary outcomes include correct performance of all seven handwashing steps, improvement in knowledge scores, and user satisfaction. A qualitative component will complement the RCT to explore participants' experiences, attitudes, and perceived barriers toward AI-based AR hand hygiene training. A purposive subsample from both arms will be invited to participate in semi-structured interviews based on the Theoretical Domains Framework. Interviews will examine usability, motivation, learning experience, and perceived behavioral changes. Data will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis with iterative coding to ensure credibility and consistency. Ethical approval will be obtained from relevant institutional review boards. All participants will be informed of their rights, including voluntary participation and the ability to withdraw at any time without penalty. Potential risks are minimal, limited mainly to rare allergic reactions to fluorescent powder. All data, including video and image recordings, will be anonymised, stored securely, and deleted one year after project completion. No personally identifiable information will be collected. This study will generate high-quality evidence on the feasibility and educational impact of integrating AI and AR technologies into hand hygiene training across academic and clinical settings. If proven effective, the system can be incorporated into health professional curricula and used at the point of care for real-time performance monitoring and auditing, contributing to sustainable infection prevention and control capacity building.

Conditions

Hand Hygiene Training; Infection Prevention and Control; Healthcare-Associated Infections (HAIs); Health Education

Keywords

hand hygiene; health education; infection prevention and control

Outcome Measures

Primary Outcomes (1)

• Change in decontamination effectiveness (percentage of fluorescent residue on both hands)

  The main outcome assesses the effectiveness of hand hygiene training by measuring the change in residual fluorescent powder percentage between the first (pre-training) and second (post-training) handwashing attempts. Fluorescent residue will be quantified using the Semmelweis Scanner™ to objectively evaluate handwashing effectiveness.

  Immediately after intervention (within the same study visit)

Secondary Outcomes (1)

• Change in hand hygiene knowledge and self-reported practice scores

  Immediately after intervention (within the same study visit)

Other Outcomes (1)

• Acceptability and perceived usefulness of the AI-based AR hand hygiene training

  Within 4-6 weeks after the training session; analysis completed by end of study period.

Study Arms (2)

Scanner Feedback + Instructional Video

ACTIVE COMPARATOR

All participants first perform a baseline handwash with fluorescent powder (no guidance). In this arm, participants view their baseline fluorescent residue results (Semmelweis Scanner™) and then watch a standard 7-step instructional video. They immediately perform a second handwash (post-training). Outcomes include change in fluorescent residue (%) and technique quality.

Behavioral: Instructional Video + Scanner Feedback

Edge AI-based AR Hand Hygiene Training

EXPERIMENTAL

All participants first perform a baseline handwash with fluorescent powder (no guidance). In this arm, participants do not view their baseline fluorescent residue. They proceed directly to AI-based AR training that provides real-time individualized feedback on the 7-step technique, then immediately perform a second handwash (post-training). Outcomes include change in fluorescent residue (%) and technique quality.

Device: Edge AI-based AR Hand Hygiene Training System

Interventions

Instructional Video + Scanner Feedback BEHAVIORAL

Viewing quantified fluorescent residue from the first handwash plus a standard 7-step instructional video prior to the second handwash.

Scanner Feedback + Instructional Video

Edge AI-based AR Hand Hygiene Training System DEVICE

An edge AI + AR system using computer vision to assess handwashing performance and deliver real-time, individualized guidance before the second handwash.

Edge AI-based AR Hand Hygiene Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergraduate students enrolled in health-related disciplines (e.g., nursing, medicine, rehabilitation sciences, medical laboratory science) at participating universities
• Healthcare professionals or supporting staff working in participating hospitals
• Able to provide informed consent
• Willing to participate in both pre- and post-training assessments during the same study visit
• Aged 18 years or above

You may not qualify if:

• Known allergy or skin irritation to fluorescent powder or hand hygiene products
• Current visible skin conditions (e.g., dermatitis, eczema, open wounds) on hands that may interfere with handwashing assessment
• Unable to understand or follow the training instructions
• Refusal or inability to provide written informed consent

Sponsors & Collaborators

• Chinese University of Hong Kong: collaborator
• The Hong Kong Polytechnic University: lead
• Tongji Hospital: collaborator

Study Sites (3)

Tongji Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

The Hong Kong Polytechnic University

Hung Hom, Hong Kong, Hong Kong

RECRUITING

The Chinese University of Hong Kong

Shatin, Hong Kong, Hong Kong

NOT YET RECRUITING

Related Publications (4)

• Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.

  PMID: 22530986 BACKGROUND

• Chen YC, Sheng WH, Wang JT, Chang SC, Lin HC, Tien KL, Hsu LY, Tsai KS. Effectiveness and limitations of hand hygiene promotion on decreasing healthcare-associated infections. PLoS One. 2011;6(11):e27163. doi: 10.1371/journal.pone.0027163. Epub 2011 Nov 16.

  PMID: 22110610 BACKGROUND

• Shin J, Kang EM, Lee SH, Heo M, Lee YJ, Lee SJ, Hong SJ, Kim JS, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Ahn CM. Prognostic implication of venoarterial extracorporeal membrane oxygenation in acute myocardial infarction-related cardiogenic shock. J Intensive Care. 2025 Jul 2;13(1):38. doi: 10.1186/s40560-025-00807-w.

  PMID: 40605095 BACKGROUND

• Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, Pittet D. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011 Jan 15;377(9761):228-41. doi: 10.1016/S0140-6736(10)61458-4. Epub 2010 Dec 9.

  PMID: 21146207 BACKGROUND

Related Links

• In WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care.

MeSH Terms

Conditions

Cross Infection; Health Education

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Lin Yang, Doctor

CONTACT

+852 2766 6398; l.yang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-11

Locations

HK (2); CN (1)