NCT06736977

Brief Summary

The goal of this clinical trial is to evaluate the effects of nurse-led education programmes on childcare workers (CCWs) in improving infection prevention and control (IPC) practices in daycare centres. The main questions it aims to answer are:

  1. 1.Is there an increase in IPC knowledge, attitudes, practices, and self-efficacy, as well as hand hygiene intention and compliance of CCWs after receiving the online or onsite IPC nurse-led education programme?
  2. 2.Do CCWs who receive the online programme exhibit higher IPC knowledge, attitudes, practices, and self-efficacy, as well as hand hygiene intention and compliance compared to those who do not receive any programme?
  3. 3.Do CCWs who receive the onsite programme exhibit higher IPC knowledge, attitudes, practices, and self-efficacy, as well as hand hygiene intention and compliance compared to those who do not receive any programme?
  4. 4.Is there a difference in IPC knowledge, attitudes, practices, and self-efficacy, as well as hand hygiene intention and compliance between CCWs who receive the online programme and those who receive the onsite programme?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

December 10, 2024

Last Update Submit

March 13, 2026

Conditions

Keywords

Nurse-led education programmeInfection controlKnowledgeAttitudePracticeSelf-efficacyHand hygiene intentionHand hygiene complianceChildcare workerChild day care centres

Outcome Measures

Primary Outcomes (4)

  • Infection prevention and control knowledge

    This questionnaire was adapted from an existing validated tool, the knowledge of preventive behaviors for communicable diseases questionnaire. It was developed based on the Disease-Free Child Care Centers Policy from the Department of Disease Control, Thailand Ministry of Public Health, to assess Thai CCWs. The original questionnaire consists of 15 dichotomous questions. The item objective congruence (IOC) was evaluated by five experts, resulting in a score of 0.744, and internal consistency was assessed with a KR-20 of 0.73 (n = 30). In this study, the researchers added five questions regarding the knowledge of using personal protective equipment, handling food and feeding, and managing waste. Therefore, the final version of this questionnaire consists of 20 dichotomous questions. The total score will be calculated by summing the correct responses, with higher scores indicating greater levels of IPC knowledge.

    From enrollment to the end of the programme at immediatly, 1 month, 3 months, and 6 months

  • Infection prevention and control attitudes

    This questionnaire was adapted from an existing validated tool, the attitudes of preventive behaviors for communicable disease questionnaire. It was developed based on the Disease-Free Child Care Centers Policy from the Department of Disease Control, Thailand Ministry of Public Health, to assess Thai CCWs. The original questionnaire consists of 15 items with five-point Likert scales. The IOC was evaluated by five experts, resulting in a score of 0.744, and internal consistency was assessed with a Cronbach's α of 0.71 (n = 30). In this study, the researchers removed questions that were outside the conceptual definition and added questions regarding beliefs, perceptions, and feelings about the importance and necessity of IPC measures. The final version of this questionnaire still consists of 15 items, including both positive and negative statements, with five-point Likert scales. The total score will be calculated, with higher scores indicating more positive attitudes toward IPC.

    From enrollment to the end of the programme at immediatly, 1 month, 3 months, and 6 months

  • Infection prevention and control practices

    This questionnaire was adapted from an existing validated tool, the preventive behaviours for communicable disease questionnaire. It was developed based on the Disease-Free Child Care Centers Policy from the Department of Disease Control, Thailand Ministry of Public Health, to assess Thai CCWs. The original questionnaire consists of 15 items with five-point Likert scales. The IOC was evaluated by five experts, resulting in a score of 0.744, and internal consistency was assessed with a Cronbach's α of 0.71 (n = 30). In this study, the researchers added five questions regarding practice of vaccination monitoring, the use of personal protective equipment (PPE), handling food and feeding, and waste management. Therefore, the final version of this questionnaire consists of 20 items with five-point Likert scales. The total score will be calculated, with higher scores indicating higher levels of IPC practices.

    From enrollment to the end of the programme at immediatly, 1 month, 3 months, and 6 months

  • Infection prevention and control self-efficacy

    This questionnaire was translated and adapted from and existing validated tool, the infectious diseases prevention self-efficacy questionnaire. It was originally used to assess self-efficacy in infectious disease prevention among Korean daycare center administrators. The questionnaire consists of 15 items with five-point Likert scales. The original tool demonstrated internal consistency with a Cronbach's α of 0.91 (n = 172). In this study, the original questionnaire was translated from English to Thai by following the WHO guidelines for the process of translation and adaptation of instruments. Additionally, the researchers removed questions that were outside the conceptual definition and added items regarding confidence in the use of PPE, handling food and feeding, and waste management. The final version of the questionnaire still consists of 15 items with five-point Likert scales. The total score will be calculated, with higher scores indicating higher levels of IPC self-efficacy.

    From enrollment to the end of the programme at immediatly, 1 month, 3 months, and 6 months

Secondary Outcomes (2)

  • Hand hygiene intention

    From enrollment to the end of the programme at immediatly, 1 month, 3 months, and 6 months

  • Hand hygiene compliance

    From enrollment to the end of the programme at immediatly, 1 month, 3 months, and 6 months

Study Arms (3)

The Onsite Nurse-Led Education Programme on IPC

EXPERIMENTAL

The researcher will conduct the Nurse-Led Education Programme on IPC for one experimental group through face-to-face/onsite delivery.

Behavioral: The Onsite Nurse-Led Education Programme on IPC

The Online Nurse-Led Education Programme on IPC

EXPERIMENTAL

The researcher will conduct the Nurse-Led Education Programme on IPC for another experimental group through online platform delivery.

Behavioral: The Online Nurse-Led Education Programme on IPC

The Control Group

NO INTERVENTION

Participants in the control group will continue their usual practice without receiving any intervention and materials until the post-intervention assessment at six months. After that, the researcher will provide the online or onsite programmes and distribute all materials.

Interventions

The online version of the nurse-led education programme was conducted using an online meeting platform. It includes the same content, learning activities, and materials as the onsite delivery programme, except for the practice stations, which cannot be provided to participants in the online delivery. Additionally, all documents will be available for download via the online platform.

The Online Nurse-Led Education Programme on IPC

The programme was designed to enhance CCWs' IPC knowledge and attitudes through lectures, interactive discussions, information sharing, and Q\&A sessions. It also aims to improve their IPC practices and self-efficacy through demonstrations, role-playing exercises, and a work assignment focused on IPC self-monitoring. The programme includes five educational sessions totalling 12 hours, along with one session for work assignment on daily self-monitoring of IPC practices over five days. The educational sessions cover the following topics: 1. General concepts of infectious diseases 2. Vaccination 3. Standard precautions: The use of personal protective equipment, environmental cleaning and disinfection, handling food and feeding, and waste management 4. Standard precautions: Hand hygiene 5. Common infectious diseases in DCCs and management.

The Onsite Nurse-Led Education Programme on IPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Registered DCCs in Bangkok, as listed in the Bangkok Metropolis Administrative information.
  • At least two or more CCWs work in DCC at the time of recruitment.
  • Participants aged 18 years or over.
  • Participants had been employed for at least three months at registered DCCs in Bangkok at the time of recruitment.
  • Participants provided care for children 0-5 years of age.
  • Participants could read and speak Thai language.

You may not qualify if:

  • Participants are attending any IPC training at the time of recruitment.
  • Participants are planning to attend another IPC training within six months after the time of recruitment.
  • Participants have completed another IPC training programme within the six months prior to the time of recruitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suan Sunandha Rajabhat University

Bangkok, Dusit, 10300, Thailand

Location

Related Publications (6)

  • Shin J, You SY. The mediating effect of self-efficacy in the relationship between communication skills and practices of preventing infectious diseases among daycare center teachers in South Korea. Child Health Nurs Res. 2021 Jan;27(1):56-64. doi: 10.4094/chnr.2021.27.1.56. Epub 2021 Jan 31.

  • Zomer TP, Erasmus V, van Empelen P, Looman C, van Beeck EF, Tjon-A-Tsien A, Richardus JH, Voeten HA. Sociocognitive determinants of observed and self-reported compliance to hand hygiene guidelines in child day care centers. Am J Infect Control. 2013 Oct;41(10):862-7. doi: 10.1016/j.ajic.2012.11.023. Epub 2013 Mar 17.

  • Zomer TP, Erasmus V, Looman CW, VAN Beeck EF, Tjon-A-Tsien A, Richardus JH, Voeten HA. Improving hand hygiene compliance in child daycare centres: a randomized controlled trial. Epidemiol Infect. 2016 Sep;144(12):2552-60. doi: 10.1017/S0950268816000911. Epub 2016 May 19.

  • Rosen L, Zucker D, Brody D, Engelhard D, Manor O. The effect of a handwashing intervention on preschool educator beliefs, attitudes, knowledge and self-efficacy. Health Educ Res. 2009 Aug;24(4):686-98. doi: 10.1093/her/cyp004. Epub 2009 Mar 24.

  • Mendes PME, de Jesus Mateus LV, Costa P. Does a Playful Intervention Promote Hand Hygiene? Compliance and Educator's Beliefs about Hand Hygiene at a Daycare Center. J Pediatr Nurs. 2020 Mar-Apr;51:e64-e68. doi: 10.1016/j.pedn.2019.08.017. Epub 2019 Sep 3.

  • Pidjadee C, Soh KL, Attharos T, Soh KG. The effect of infection prevention and control programme for childcare workers in daycare centres: A systematic review. J Pediatr Nurs. 2024 Nov-Dec;79:116-125. doi: 10.1016/j.pedn.2024.09.002. Epub 2024 Sep 9.

Related Links

MeSH Terms

Conditions

Behavior

Study Officials

  • Chakkrich Pidjadee

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 17, 2024

Study Start

February 1, 2025

Primary Completion

December 15, 2025

Study Completion

December 30, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations