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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Gaming for Medical Education Research Program: An Investigator-blinded, Randomised Controlled Trial on Serious Games for Doctors, Nurses and Students.
Secondary ID [1] 0 0
HC17160-LNR/17/SCHN/194
Universal Trial Number (UTN)
Trial acronym
G4MER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Education, Medical 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Multiple choice quiz score
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Primary outcome [2] 0 0
Asthma observed structured clinical examination (OSCE) score
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Primary outcome [3] 0 0
Seizure observed structured clinical examination (OSCE) scoresimulation lab)
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Secondary outcome [1] 0 0
Participant attitudes towards educational intervention
Assessment method [1] 0 0
Mixed-methods analysis survey. 5-point Likert scale from "Strongly Agree" to "Strongly Disagree".
Timepoint [1] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Secondary outcome [2] 0 0
Time to specific actions in OSCE scenarios
Assessment method [2] 0 0
E.g. calling for help, oxygen supplementation, salbutamol, anti-epileptic drug
Timepoint [2] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Secondary outcome [3] 0 0
Anti-epileptic medication(s) administered at correct time during OSCE scenario
Assessment method [3] 0 0
E.g. Midazolam or diazepam correctly administered at 5 minutes of seizure activity (yes/no).
Timepoint [3] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).

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.
Minimum age
20 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2022
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Coffey, BMed MD
Address 0 0
The University of New South Wales
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael J Coffey, BMed MD
Address 0 0
Country 0 0
Phone 0 0
011 61 2 9382 5574
Email 0 0
michael.coffey@unsw.edu.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03666468