NCT04076163

Brief Summary

Background: serious games have been reported as valuable method of learning since a decade. Even if their evident efficiency hasn't been always reported, their influence on the learners' motivation has become consensual. The authors aim to assess the efficacy of using serious games to teach critical appraisal practice to medical students in comparison to face-to-face learning methods. Material and methods: the authors will perform a cluster randomised controlled trial including third-year medical students. Both groups will receive the same initial learning about elementary principals of evidence-based-medicine. Then, the control group will perform a critical appraisal of a case report and a recommendation article guided by a checklist and the intervention group performed a critical appraisal of the same manuscripts using a home-made serious game. Both groups will be invited to fulfil a multiple-choice-question test and a satisfaction likert-scale questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration 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

September 2, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

August 16, 2019

Last Update Submit

August 29, 2019

Conditions

Healthy Students

Outcome Measures

Primary Outcomes (1)

  • Critical appraisal score

    10 multiple choice questions with score /20

    12 months

Secondary Outcomes (1)

  • Satisfaction questionnaire

    12 months

Study Arms (2)

control group

NO INTERVENTION

group of students participating to a face-to-face learning

intervention group

OTHER

group of students using serious game

Other: serious game

Interventions

serious gameOTHER

a serious game was performed by the investigators in order to enhance the critical appraisal practice of students

intervention group

Eligibility Criteria

Age20 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Third-year medical students
  • Students in the department of Pathology

You may not qualify if:

  • Other medical students
  • Non consenting students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mona Mlika

Tunis, 2037, Tunisia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 16, 2019

First Posted

September 3, 2019

Study Start

September 2, 2017

Primary Completion

June 30, 2019

Study Completion

July 1, 2019

Last Updated

September 3, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)