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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03666468
Registration number
NCT03666468
Ethics application status
Date submitted
14/08/2018
Date registered
11/09/2018
Date last updated
31/07/2019
Titles & IDs
Public title
The Gaming for Medical Education Research (G4MER) Program
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Scientific title
Gaming for Medical Education Research Program: An Investigator-blinded, Randomised Controlled Trial on Serious Games for Doctors, Nurses and Students.
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Secondary ID [1]
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HC17160-LNR/17/SCHN/194
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Universal Trial Number (UTN)
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Trial acronym
G4MER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Education, Medical
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - PlayMed
Other interventions - Online Package
Other interventions - Paper Guidelines
Experimental: PlayMed - PlayMed, a highly immersive role-playing computer game
- Focus on Paediatric Asthma and Seizure management
Active Comparator: Online Package (OP) - Online package (OP) of NSW Health Guidelines
- Focus on Paediatric Asthma and Seizure management
Placebo Comparator: Paper Guidelines - Paper NSW Health Guidelines
- Focus on Paediatric Asthma and Seizure management
Other interventions: PlayMed
A highly immersive role-playing computer game focused on Paediatric Asthma and Seizure management
Other interventions: Online Package
Online package (OP) of NSW Health Guidelines focused on Paediatric Asthma and Seizure management
Other interventions: Paper Guidelines
Paper NSW Health Guideline focused on Paediatric Asthma and Seizure management
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Multiple choice quiz score
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Assessment method [1]
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A paper-based assessment using multiple choice questions designed to test knowledge acquisition for asthma and seizure management. For Studies 1A and 1B, scale 0 to 10, higher is better performance. Studies 2A and 2B, scale from 0 to 15, higher is better.
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Timepoint [1]
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Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
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Primary outcome [2]
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Asthma observed structured clinical examination (OSCE) score
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Assessment method [2]
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An OSCE administered in a high-fidelity simulation lab. A child with an exacerbation of asthma will be presented and the management required will need to be implemented by the participant. For Studies 1A and 1B, subscale from 0 to 15, higher is better, with scores summed with Outcome 3. Studies 2A and 2B, subscale from 0 to 25, higher is better, with scores summed with Outcome 3.
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Timepoint [2]
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Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
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Primary outcome [3]
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Seizure observed structured clinical examination (OSCE) scoresimulation lab)
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Assessment method [3]
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An OSCE administered in a high-fidelity simulation lab. A child with a seizure will be presented and the management required will need to be implemented by the participant. For Studies 1A and 1B, subscale from 0 to 15, higher is better, with scores summed with Outcome 3. Studies 2A and 2B, subscale from 0 to 25, higher is better, with scores summed with Outcome 2.
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Timepoint [3]
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Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
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Secondary outcome [1]
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Participant attitudes towards educational intervention
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Assessment method [1]
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Mixed-methods analysis survey. 5-point Likert scale from "Strongly Agree" to "Strongly Disagree".
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Timepoint [1]
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Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
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Secondary outcome [2]
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Time to specific actions in OSCE scenarios
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Assessment method [2]
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E.g. calling for help, oxygen supplementation, salbutamol, anti-epileptic drug
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Timepoint [2]
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Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
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Secondary outcome [3]
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Anti-epileptic medication(s) administered at correct time during OSCE scenario
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Assessment method [3]
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E.g. Midazolam or diazepam correctly administered at 5 minutes of seizure activity (yes/no).
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Timepoint [3]
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Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
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Eligibility
Key inclusion criteria
- Studies 1A and 2A Phase 2 or 3 medical students at UNSW who are enrolled in the
Children's Health Course will be eligible
- Studies 1B and 2B Doctors and nurses employed at Sydney Children's Hospital.
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Minimum age
20
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Studies 1A and 2A Medical students not actively enrolled at UNSW
- Studies 1B and 2B Doctors and nurses not actively employed at Sydney Children's
Hospital.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2022
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Actual
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Sample size
Target
264
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of New South Wales
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The "G4MER" Program aims to investigate whether serious games add value to medical education
in comparison to an online learning package or clinical practice guidelines. The
investigators will perform a series of investigator-blinded randomised control trials on
doctors, nurses, and medical students at Sydney Children's Hospital. Participants will be
given access to their randomly allocated intervention for 8 weeks or 5 days, and will be
assessed using multiple choice questions (MCQ) and two observed structure clinical
examination (OSCE) stations. Participant attitudes will also be assessed through a
mixed-methods questionnaire.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03666468
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael J Coffey, BMed MD
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Address
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The University of New South Wales
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Michael J Coffey, BMed MD
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Address
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Country
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Phone
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011 61 2 9382 5574
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03666468
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