NCT03486275

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,398

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

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

May 31, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

March 27, 2018

Last Update Submit

April 8, 2018

Conditions

CONTINUING MEDICAL EDUCATION

Keywords

GENERAL PRACTICESERIOUS GAMEEVIDENCE BASED MEDICINERANDOMIZED CONTROLLED TRIALPEDAGOGY

Outcome Measures

Primary Outcomes (2)

  • Knowledge test

    Mean score at a final knowledge test

    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

    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

    one week after randomization (end of access to support)

  • Playing time

    during the first week of access to support of intervention

  • Use in practice

    completed 3 to 5 weeks after the end of the intervention, i.e. 4 to 6 weeks after randomization

Study Arms (2)

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).

Device: Hygie

Source articles

ACTIVE COMPARATOR

9 articles from independent journals based on evidence (reviews by Prescrire and Minerva)

Device: Source articles

Interventions

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).

Hygie game
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.

Source articles

Eligibility Criteria

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

You may qualify if:

  • to be a french general practice clinical supervisor

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paris Diderot University

Paris, 75018, France

Location

Related Publications (1)

  • 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.

    PMID: 31746775DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blinded randomized trial : Participants do not know their assignment group. The questionnaires, identical in both groups, were completed by the participants and blinded from their assignment group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized trial comparing the learning provided by a week of access to the game Hygie or source articles
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 3, 2018

Study Start

May 31, 2017

Primary Completion

September 6, 2017

Study Completion

September 6, 2017

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
if asked
Access Criteria
requests will be considered individually

Locations

FR(1)