CONTINUING MEDICAL EDUCATIONNCT03486275
Development and Evaluation of Hygie, a New Serious Game for Continuing Medical Education of General Practitioners
A study testing Hygie and Source articles in people with CONTINUING MEDICAL EDUCATION, run by Hygie at 1 site in France.
Trial summary
We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CONTINUING MEDICAL EDUCATION
- What is being tested?
- Hygie and Source articles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,398 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2017to 6 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- to be a french general practice clinical supervisor
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of Hygie, a New Serious Game for Continuing Medical Education of General Practitioners: a Randomized Trial
We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). We then carried out a randomized trial comparing the learning provided by a week of access to the game versus source articles, in a population of clinical supervisors (CS) from 13 French departments of general practice.
Read the detailed description
Continuing medical education is important but burdensome work for general practitioners. Current training tools have limitations and may lack the ability to engage some practitioners. Serious games are new pedagogical tools that use video games as engaging education tools. They have significant advantages in terms of efficiency and dissemination.
The aim of this work was to create a new serious game and to evaluate it in terms of efficiency and satisfaction, comparing it with a traditional method of continuing education: article reading.
We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). We then carried out a randomized trial comparing the learning provided by a week of access to the game versus source articles, in a population of clinical supervisors (CS) from 14 French departments of general practice.
- Conditions
- CONTINUING MEDICAL EDUCATION
- Being tested
- Hygie, Source articles
- Keywords
- GENERAL PRACTICE, SERIOUS GAME, EVIDENCE BASED MEDICINE, RANDOMIZED CONTROLLED TRIAL, PEDAGOGY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HygieDevice
Prototype video game called Hygie, accessible on the Internet, on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva).
Source articlesDevice
9 articles from independent journals based on evidence (reviews by Prescrire and Minerva), about the 5 most common reasons of consultation in general practice, accessible on the Internet.
| Study group | Role | What they receive |
|---|---|---|
| Hygie game | Active comparator | Prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). Receives: Device: Hygie |
| Source articles | Active comparator | 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva) Receives: Device: Source articles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge test
Mean score at a final knowledge test
Measured: completed 3 to 5 weeks after the end of the intervention, i.e. 4 to 6 weeks after randomization
Delta knowledge
Mean difference score between knowledge pretest and final knowledge test (posttest
Measured: pretest before randomization, posttest 3 to 5 weeks after the end of the intervention (i.e. 4 to 6 weeks after randomization)
Secondary outcomes (3)
Satisfaction
Satisfaction survey completed at the end of the intervention access week
Measured: one week after randomization (end of access to support)
Playing time
Time spended playing by subjects assigned to Hygie
Measured: during the first week of access to support of intervention
Use in practice
completed 3 to 5 weeks after the end of the intervention, participants answer the question "In the course of your practice, did you use the knowledge you learned through the teaching material?"
Measured: completed 3 to 5 weeks after the end of the intervention, i.e. 4 to 6 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start31 May 2017
- Primary completion6 Sep 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CONTINUING MEDICAL EDUCATIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial comparing the learning provided by a week of access to the game Hygie or source articles
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hygie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis-Baptiste Jaunay, Hygie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486275
- Sponsor's protocol ID
- Hygie1
- Status last verified
- Apr 2018
- First submitted
- 27 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Jaunay LB, Zerr P, Peguin L, Renouard L, Ivanoff AS, Picard H, Griffith J, Chassany O, Duracinsky M. Development and Evaluation of a New Serious Game for Continuing Medical Education of General Practitioners (Hygie): Double-Blinded Randomized Controlled Trial. J Med Internet Res. 2019 Nov 20;21(11):e12669. doi: 10.2196/12669.
PubMed 31746775
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Hygie, a New Serious Game for Continuing Medical Education of General Practitioners: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03486275
- Acronym / sponsor ID
- Hygie1
- Conditions
- CONTINUING MEDICAL EDUCATION
- Keywords
- GENERAL PRACTICE, SERIOUS GAME, EVIDENCE BASED MEDICINE, RANDOMIZED CONTROLLED TRIAL, PEDAGOGY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,398 participants (actual)
- Lead sponsor
- HygieUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). We then carried out a randomized trial comparing the learning provided by a week of access to the game versus source articles, in a population of clinical supervisors (CS) from 13 French departments of general practice.
Detailed description
Continuing medical education is important but burdensome work for general practitioners. Current training tools have limitations and may lack the ability to engage some practitioners. Serious games are new pedagogical tools that use video games as engaging education tools. They have significant advantages in terms of efficiency and dissemination.
The aim of this work was to create a new serious game and to evaluate it in terms of efficiency and satisfaction, comparing it with a traditional method of continuing education: article reading.
We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). We then carried out a randomized trial comparing the learning provided by a week of access to the game versus source articles, in a population of clinical supervisors (CS) from 14 French departments of general practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized trial comparing the learning provided by a week of access to the game Hygie or source articles
| Arm | Type | Receives |
|---|---|---|
| Hygie game | Active comparator | Device: HygiePrototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). |
| Source articles | Active comparator | Device: Source articles9 articles from independent journals based on evidence (reviews by Prescrire and Minerva) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- to be a french general practice clinical supervisor
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HygiePrototype video game called Hygie, accessible on the Internet, on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). | Device | Hygie game |
| Source articles9 articles from independent journals based on evidence (reviews by Prescrire and Minerva), about the 5 most common reasons of consultation in general practice, accessible on the Internet. | Device | Source articles |
Primary outcome
Knowledge test
Time frame: completed 3 to 5 weeks after the end of the intervention, i.e. 4 to 6 weeks after randomization
Mean score at a final knowledge test
Delta knowledge
Time frame: pretest before randomization, posttest 3 to 5 weeks after the end of the intervention (i.e. 4 to 6 weeks after randomization)
Mean difference score between knowledge pretest and final knowledge test (posttest
3 secondary outcomes
Satisfaction
Time frame: one week after randomization (end of access to support)
Playing time
Time frame: during the first week of access to support of intervention
Use in practice
Time frame: completed 3 to 5 weeks after the end of the intervention, i.e. 4 to 6 weeks after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Derived from this study: PubMed 31746775Jaunay LB, Zerr P, Peguin L, Renouard L, Ivanoff AS, Picard H, Griffith J, Chassany O, Duracinsky M. Development and Evaluation of a New Serious Game for Continuing Medical Education of General Practitioners (Hygie): Double-Blinded Randomized Controlled Trial. J Med Internet Res. 2019 Nov 20;21(11):e12669. doi: 10.2196/12669.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hygie and Source articles in people with CONTINUING MEDICAL EDUCATION, run by Hygie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge test (time frame: completed 3 to 5 weeks after the end of the intervention, i.e. 4 to 6 weeks after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03486275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.