NCT05317988

Brief Summary

The COVID-19 vaccine by BioNTech requires specific, delicate storage and dilution procedures to be stringently followed for safety and effectiveness. Training should be completed prior to undertaking dilution procedures. Currently, the nursing and pharmacy curricula do not have content on specialized vaccine reconstitution techniques. E-learning has become an essential component of teaching and learning due to COVID. Yet, optimal online learning module development for clinical procedural skill acquisition and appropriate online formative assessment has not been adequately explored. To bridge this training gap for Hong Kong nurses and pharmacists, this project aims to develop a video-based online learning programme, coupled to a randomized controlled study to determine the effectiveness of online vaccine reconstitution training. The module, a supplement to the current teaching curriculum, will train students from both Nursing and Pharmacy disciplines. Outcome measures include formative assessment of student performance, which can be used to inform the design and content of experiential content in healthcare professional curriculums. If this learning platform is shown to be effective, the scope could be extended to other disciplines (not limited to healthcare) where learning complex procedural tasks are necessary for the absence of instructor-led teaching.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Mar 2022

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

Study Start

First participant enrolled

March 28, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

April 6, 2022

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Factual knowledge

    Students will complete a set of validated multiple-choice questions before and after the training.

    1 week

Secondary Outcomes (2)

  • Procedural knowledge

    1 week

  • Self-efficacy

    1 week

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive a step-by-step demonstration video of detailed reconstitution procedures and text-based vaccine product information

Behavioral: Intervention group

Control group

PLACEBO COMPARATOR

Participants receive a generic video of similar duration on basic facts of COVID-19 (unrelated to reconstitution procedures) and text-based product information

Behavioral: Control group

Interventions

Participants receive a step-by-step demonstration video of detailed reconstitution procedures and text-based vaccine product information

Intervention group
Control groupBEHAVIORAL

Participants receive a generic video of similar duration on basic facts of COVID-19 (unrelated to reconstitution procedures) and text-based product information

Control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students currently enrolled in the Bachelor of Pharmacy and Bachelor of Nursing programmes (Years 1 to 4) at The University of Hong Kong

You may not qualify if:

  • Students not from the aforementioned programmes and years of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Safe Medication Practice and Research

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

COVID-19

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 8, 2022

Study Start

March 28, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations