NCT03092440

Brief Summary

The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and patient outcome. Serious games are useful educational tools since they allow both theory and practice training for an important number of learners, simultaneously. However, few studies have evaluated the validity and effectiveness of serious games. Our simulation unit (LabForSIMS- Faculté de Médecine Paris-Sud, France) has developed a serious game named "LabForGames Warning" for nursing students with the following learning objectives: to recognize and to address the degradation of a patient's clinical condition and to work on the issue of inter-professional communication. The aim of the present study is to determine content and construct validities of the "LabForGames Warning" serious game before its use as a healthcare professional training tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

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

March 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

March 14, 2017

Last Update Submit

November 20, 2018

Conditions

Keywords

Medical Educationsimulationserious gamevalidity

Outcome Measures

Primary Outcomes (2)

  • The score (/100) of each case of the serious game

    The score (/100) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups (Evaluation of the construct validity). An auto-evaluation of clinical reasoning will also be recorded.

    60 min

  • the duration (min) of each case of the serious game

    The duration (min) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups (Evaluation of the construct validity).

    60 min

Secondary Outcomes (3)

  • The content and parameters of the serious game

    30 min

  • Learners' satisfaction

    5 min

  • The resemblance between the virtual game and the real life clinical practice

    25 min

Study Arms (3)

"Nursing students" group

nursing students

Other: serious game

"New nurses" group

Nurses with \< 2 years experience

Other: serious game

"Expert nurses" group

Intensive nurses (with ≥ 4 years experience post graduate)

Other: serious game

Interventions

During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game.

"Expert nurses" group"New nurses" group"Nursing students" group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Voluntary divided into three groups : * "Nursing students" group * "New nurses" group: Nurses with \< 2 years experience * "Expert nurses" group: Intensive nurses (with ≥ 4 years experience post graduate)

You may qualify if:

  • Nursing students or nurses with \< 2 years experience or intensive nurses (with ≥ 4 years experience post graduate)
  • and having agreed to participate

You may not qualify if:

  • Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (\< 18 years)
  • Refusal to participate in to the study Refusal to sign in the confidentiality clause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculté de médecine Paris Sud

Le Kremlin-Bicêtre, 94276, France

Location

Related Publications (1)

  • Blanie A, Amorim MA, Meffert A, Perrot C, Dondelli L, Benhamou D. Assessing validity evidence for a serious game dedicated to patient clinical deterioration and communication. Adv Simul (Lond). 2020 May 27;5:4. doi: 10.1186/s41077-020-00123-3. eCollection 2020.

Study Officials

  • Antonia Blanié, M.D

    Université Paris Sud, 91 400 Orsay, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Antonia Blanie M D

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 28, 2017

Study Start

March 1, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations