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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04592432
Other study ID # CERSES-20-123-D
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2020
Est. completion date December 8, 2020

Study information

Verified date April 2021
Source Université de Montréal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 8, 2020
Est. primary completion date December 8, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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).
SIGN@L-B
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.

Locations

Country Name City State
Canada Université de Montréal Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Marc-André Maheu-Cadotte

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Engagement with 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
Primary Engagement with 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
Primary Intrinsic motivation toward 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
Primary Intrinsic motivation toward 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
Primary Change in clinical reasoning in the context of acute heart failure 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
Primary Change in clinical reasoning in the context of acute heart failure 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 Time spent playing with 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
Secondary Time spent playing with 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
Secondary Degree to which the participant would like to play again with 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
Secondary Degree to which the participant would like to play again with 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
Secondary Favorite prototype of the serious game Participants indicate on a questionnaire which prototype they preferred (SIGN@L-A or SIGN@L-B) Up to 14 days post-randomization
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