- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04592432
Development of an Educational Video Game to Improve Nursing Students' Reasoning With Acute Heart Failure Patients
April 26, 2021 updated by: Marc-André Maheu-Cadotte
Development of a Serious Game to Improve Nursing Students' Clinical Reasoning in the Context of Acute Heart Failure
The aim of this study is to appreciate, using quantitative and qualitative empirical methods, the contribution of an educational video game to the engagement, the motivation, and the development of nursing students' interpretation of acute heart failure patients' health condition.
Two prototypes of the same educational video game have been developed.
Study participants will play with both prototypes, complete online questionnaires and be interviewed by a research assistant regarding their experience with both prototypes.
Study results will serve to select the most promising prototype between the two, based on its potential to support the engagement, the motivation, and the development of nursing students' interpretation of acute heart failure patients' health condition.
Study results will also serve to refine the selected prototype before conducting a larger-scale efficacy trial.
As such and given the small sample number of participants that is expected, it is not planned to conduct hypothesis testing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1J4
- Université de Montréal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- As part of a Bachelor of Nursing program, to be registered in a course in which acute heart failure concepts are a focus.
Exclusion Criteria:
- No exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SIGN@L-A followed by SIGN@L-B
Participants in this arm will have access to the prototype "SIGN@L-A" of the serious game for seven days.
They will have access to this prototype from their personal computer and will be able to play with it whenever they want and for how long they wish during this period.
After these seven days, they will have access the same way to the prototype "SIGN@L-B".
|
Two prototypes of a serious game were developed as part of this study.
The design of these prototypes is based on the conceptual model by Alexiou and Schippers (2018) linking the instructional design of a serious game to intrinsic motivation, engagement, and learning outcomes.
The design of SIGN@L-A will include all elements of the serious game instructional design proposed by these authors which are game mechanics (i.e., objectives to meet, feedback, and rewards), a narrative (i.e., a protagonist, non-playable characters, and narrative events), and aesthetics (i.e., functional and hedonic aesthetics).
The design of SIGN@L-B will include only some of these elements which are some of the game mechanics (i.e., objectives to meet, limited feedback), and a functional aesthetic.
|
|
Experimental: SIGN@L-B followed by SIGN@L-A
Participants in this arm will have access to the prototype "SIGN@L-B" of the serious game for seven days.
They will have access to this prototype from their personal computer and will be able to play with it whenever they want and for how long they wish during this period.
After these seven days, they will have access the same way to the prototype "SIGN@L-A".
|
Two prototypes of a serious game were developed as part of this study.
The design of these prototypes is based on the conceptual model by Alexiou and Schippers (2018) linking the instructional design of a serious game to intrinsic motivation, engagement, and learning outcomes.
The design of SIGN@L-A will include all elements of the serious game instructional design proposed by these authors which are game mechanics (i.e., objectives to meet, feedback, and rewards), a narrative (i.e., a protagonist, non-playable characters, and narrative events), and aesthetics (i.e., functional and hedonic aesthetics).
The design of SIGN@L-B will include only some of these elements which are some of the game mechanics (i.e., objectives to meet, limited feedback), and a functional aesthetic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Engagement with SIGN@L-A
Time Frame: Up to a week after being assigned to SIGN@L-A
|
Measured with the French version of the User Engagement Scale - Short Form (Fontaine et al., 2019; O'Brien et al., 2018).
This is a self-reported 5-level Likert -type scale (1 to 5).
The overall score varies from 1 to 5 where a higher score is indicative of a greater engagement.
|
Up to a week after being assigned to SIGN@L-A
|
|
Engagement with SIGN@L-B
Time Frame: Up to a week after being assigned to SIGN@L-B
|
Measured with the French version of the User Engagement Scale - Short Form (Fontaine et al., 2019; O'Brien et al., 2018).
This is a self-reported 5-level Likert -type scale (1 to 5).
The overall score varies from 1 to 5 where a higher score is indicative of a greater engagement.
|
Up to a week after being assigned to SIGN@L-B
|
|
Intrinsic motivation toward SIGN@L-A
Time Frame: Up to a week after being assigned to SIGN@L-A
|
Measured with the corresponding subscale of the Échelle de motivation situationnelle (Guay et al., 2000).
This is a self-reported 7-level Likert-type subscale (1 to 7).
The overall score varies from 4 to 28 where a higher score is indicative of a greater intrinsic motivation.
|
Up to a week after being assigned to SIGN@L-A
|
|
Intrinsic motivation toward SIGN@L-B
Time Frame: Up to a week after being assigned to SIGN@L-B
|
Measured with the corresponding subscale of the Échelle de motivation situationnelle (Guay et al., 2000).
This is a self-reported 7-level Likert-type subscale (1 to 7).
The overall score varies from 4 to 28 where a higher score is indicative of a greater intrinsic motivation.
|
Up to a week after being assigned to SIGN@L-B
|
|
Change in clinical reasoning in the context of acute heart failure
Time Frame: At baseline; up to seven days post-randomization
|
Measured with an ad hoc questionnaire.
Ten grids are presented to the participant.
In each grid, a logical network between two highlighted elements must be developed.
Each element refers to a concept related to acute heart failure.
Each grid is then rated incorrect (0) or correct (1).
The overall score varies from 0 to 10 where a higher score indicates a better clinical reasoning in the context of acute heart failure.
|
At baseline; up to seven days post-randomization
|
|
Change in clinical reasoning in the context of acute heart failure
Time Frame: At baseline; between seven and fourteen days post-randomization
|
Measured with an ad hoc questionnaire.
Ten grids are presented to the participant.
In each grid, a logical network between two highlighted elements must be developed.
Each element refers to a concept related to acute heart failure.
Each grid is then rated incorrect (0) or correct (1).
The overall score varies from 0 to 10 where a higher score indicates a better clinical reasoning in the context of acute heart failure.
|
At baseline; between seven and fourteen days post-randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time spent playing with SIGN@L-A
Time Frame: Up to a week after being assigned to SIGN@L-A
|
Self-reported number of minutes estimated to have been spent playing.
|
Up to a week after being assigned to SIGN@L-A
|
|
Time spent playing with SIGN@L-B
Time Frame: Up to a week after being assigned to SIGN@L-B
|
Self-reported number of minutes estimated to have been spent playing.
|
Up to a week after being assigned to SIGN@L-B
|
|
Degree to which the participant would like to play again with SIGN@L-A
Time Frame: Up to a week after being assigned to SIGN@L-A
|
Measured with a self-reported 10-point scale (0: not at all; 10; a lot).
The score varies from 0 to 10 where a higher score indicates a higher degree to which the participant would like to play again with the serious game.
|
Up to a week after being assigned to SIGN@L-A
|
|
Degree to which the participant would like to play again with SIGN@L-B
Time Frame: Up to a week after being assigned to SIGN@L-B
|
Measured with a self-reported 10-point scale (0: not at all; 10; a lot).
The score varies from 0 to 10 where a higher score indicates a higher degree to which the participant would like to play again with the serious game.
|
Up to a week after being assigned to SIGN@L-B
|
|
Favorite prototype of the serious game
Time Frame: Up to 14 days post-randomization
|
Participants indicate on a questionnaire which prototype they preferred (SIGN@L-A or SIGN@L-B)
|
Up to 14 days post-randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc-André Maheu-Cadotte, PhD(c), Université de Montréal
- Study Director: Patrick Lavoie, PhD, Université de Montréal
- Study Director: Véronique Dubé, PhD, Université de Montréal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2020
Primary Completion (Actual)
December 8, 2020
Study Completion (Actual)
December 8, 2020
Study Registration Dates
First Submitted
October 6, 2020
First Submitted That Met QC Criteria
October 12, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERSES-20-123-D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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