search
Back to results

Development of an Educational Video Game to Improve Nursing Students' Reasoning With Acute Heart Failure Patients

Primary Purpose

Heart Failure, Motivation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SIGN@L-A
SIGN@L-B
Sponsored by
Marc-André Maheu-Cadotte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Clinical reasoning, Intrinsic motivation, Serious gaming, Nursing education, Undergraduate education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SIGN@L-A followed by SIGN@L-B

SIGN@L-B followed by SIGN@L-A

Arm Description

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".

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".

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Time spent playing with SIGN@L-A
Self-reported number of minutes estimated to have been spent playing.
Time spent playing with SIGN@L-B
Self-reported number of minutes estimated to have been spent playing.
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.
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.
Favorite prototype of the serious game
Participants indicate on a questionnaire which prototype they preferred (SIGN@L-A or SIGN@L-B)

Full Information

First Posted
October 6, 2020
Last Updated
April 26, 2021
Sponsor
Marc-André Maheu-Cadotte
search

1. Study Identification

Unique Protocol Identification Number
NCT04592432
Brief Title
Development of an Educational Video Game to Improve Nursing Students' Reasoning With Acute Heart Failure Patients
Official Title
Development of a Serious Game to Improve Nursing Students' Clinical Reasoning in the Context of Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
December 8, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marc-André Maheu-Cadotte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Motivation
Keywords
Clinical reasoning, Intrinsic motivation, Serious gaming, Nursing education, Undergraduate education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The quantitative component is a two-group randomized crossover trial with 1:1 group allocation. Each participant will be randomly allocated to one of the two intervention sequences (i.e., the serious game SIGN@L-A followed by the serious game SIGN@L-B or vice versa). The randomization sequence list will be generated by an individual independent to quantitative data collection using an online program (randomizer.org). The primary investigator will not have access to this list. This individual will inform the primary investigator of participants' allocation after they have consented to be randomized, their randomization order based on the exact time they have completed the online consent form. Block randomization will be used with block sizes of six to avoid imbalances in group sizes.
Masking
None (Open Label)
Masking Description
Due to the nature of the interventions evaluated, participants cannot be blinded to group allocation. Furthermore, since the primary investigator is a PhD candidate and that this is his doctoral project, he will also not be blinded to group allocation as he will be responsible for assigning participants to one of the two intervention sequences and provide technical support, if needed.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIGN@L-A followed by SIGN@L-B
Arm Type
Experimental
Arm Description
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".
Arm Title
SIGN@L-B followed by SIGN@L-A
Arm Type
Experimental
Arm Description
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".
Intervention Type
Other
Intervention Name(s)
SIGN@L-A
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
SIGN@L-B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Engagement with SIGN@L-A
Description
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.
Time Frame
Up to a week after being assigned to SIGN@L-A
Title
Engagement with SIGN@L-B
Description
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.
Time Frame
Up to a week after being assigned to SIGN@L-B
Title
Intrinsic motivation toward SIGN@L-A
Description
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.
Time Frame
Up to a week after being assigned to SIGN@L-A
Title
Intrinsic motivation toward SIGN@L-B
Description
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.
Time Frame
Up to a week after being assigned to SIGN@L-B
Title
Change in clinical reasoning in the context of acute heart failure
Description
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.
Time Frame
At baseline; up to seven days post-randomization
Title
Change in clinical reasoning in the context of acute heart failure
Description
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.
Time Frame
At baseline; between seven and fourteen days post-randomization
Secondary Outcome Measure Information:
Title
Time spent playing with SIGN@L-A
Description
Self-reported number of minutes estimated to have been spent playing.
Time Frame
Up to a week after being assigned to SIGN@L-A
Title
Time spent playing with SIGN@L-B
Description
Self-reported number of minutes estimated to have been spent playing.
Time Frame
Up to a week after being assigned to SIGN@L-B
Title
Degree to which the participant would like to play again with SIGN@L-A
Description
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.
Time Frame
Up to a week after being assigned to SIGN@L-A
Title
Degree to which the participant would like to play again with SIGN@L-B
Description
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.
Time Frame
Up to a week after being assigned to SIGN@L-B
Title
Favorite prototype of the serious game
Description
Participants indicate on a questionnaire which prototype they preferred (SIGN@L-A or SIGN@L-B)
Time Frame
Up to 14 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc-André Maheu-Cadotte, PhD(c)
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Lavoie, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Véronique Dubé, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Study Director
Facility Information:
Facility Name
Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1J4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development of an Educational Video Game to Improve Nursing Students' Reasoning With Acute Heart Failure Patients

We'll reach out to this number within 24 hrs