Heart FailureNCT04592432

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

A study testing SIGN@L-A and SIGN@L-B in people with Heart Failure and Motivation, run by Marc-André Maheu-Cadotte at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Heart Failure, Motivation
What is being tested?: SIGN@L-A and SIGN@L-B
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteCanada
Study dates: 13 Oct 2020to 8 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

As part of a Bachelor of Nursing program, to be registered in a course in which acute heart failure concepts are a focus.

Who cannot join

No exclusion criteria

Trial locations and contacts

1 site in 1 country.

Canada1 site

Université de Montréal
Montreal, Quebec, H3T 1J4

Other trials in Canada

About this study

Official title: 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.

Conditions: Heart Failure, Motivation
Being tested: SIGN@L-A, SIGN@L-B
Keywords: Clinical reasoning, Intrinsic motivation, Serious gaming, Nursing education, Undergraduate education
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SIGN@L-AOther
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-BOther
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.

Study groups in NCT04592432
Study group	Role	What they receive
SIGN@L-A followed by SIGN@L-B	Experimental	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". Receives: Other: SIGN@L-A; Other: SIGN@L-B
SIGN@L-B followed by SIGN@L-A	Experimental	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". Receives: Other: SIGN@L-A; Other: SIGN@L-B

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to a week after being assigned to SIGN@L-A
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.
Measured: Up to a week after being assigned to SIGN@L-B
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.
Measured: Up to a week after being assigned to SIGN@L-A
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.
Measured: Up to a week after being assigned to SIGN@L-B
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.
Measured: At baseline; up to seven days post-randomization
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.
Measured: At baseline; between seven and fourteen days post-randomization

Secondary outcomes (5)

Time spent playing with SIGN@L-A
Self-reported number of minutes estimated to have been spent playing.
Measured: Up to a week after being assigned to SIGN@L-A
Time spent playing with SIGN@L-B
Self-reported number of minutes estimated to have been spent playing.
Measured: 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
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.
Measured: 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
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.
Measured: Up to a week after being assigned to SIGN@L-B
Favorite prototype of the serious game
Participants indicate on a questionnaire which prototype they preferred (SIGN@L-A or SIGN@L-B)
Measured: Up to 14 days post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 20208 Dec 2020

First posted19 Oct 2020
Study start13 Oct 2020
Primary completion8 Dec 2020
Study completion8 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
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)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04592432
Sponsor's protocol ID: CERSES-20-123-D
Status last verified: Apr 2021
First submitted: 6 Oct 2020
Last updated: 28 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Maheu-Cadotte MA, Dube V, Lavoie P. Development and Contribution of a Serious Game to Improve Nursing Students' Clinical Reasoning in Acute Heart Failure: A Multimethod Study. Comput Inform Nurs. 2023 Jun 1;41(6):410-420. doi: 10.1097/CIN.0000000000000966.
PubMed 36729896

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a Serious Game to Improve Nursing Students' Clinical Reasoning in the Context of Acute Heart Failure
ClinicalTrials.gov ID: NCT04592432
Acronym / sponsor ID: CERSES-20-123-D
Conditions: Heart Failure, Motivation
Keywords: Clinical reasoning, Intrinsic motivation, Serious gaming, Nursing education, Undergraduate education
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Marc-André Maheu-CadotteUniversity, hospital or other
Study start: 13 Oct 2020 (actual)
Primary completion: 8 Dec 2020 (actual)
Study completion: 8 Dec 2020 (actual)
First posted: 19 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
SIGN@L-A followed by SIGN@L-B	Experimental	Other: SIGN@L-A, Other: SIGN@L-BParticipants 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".
SIGN@L-B followed by SIGN@L-A	Experimental	Other: SIGN@L-A, Other: SIGN@L-BParticipants 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".

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

As part of a Bachelor of Nursing program, to be registered in a course in which acute heart failure concepts are a focus.

Key exclusion criteria (1 listed)

No exclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SIGN@L-ATwo 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).	Other	SIGN@L-A followed by SIGN@L-B, SIGN@L-B followed by SIGN@L-A
SIGN@L-BThe 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.	Other	SIGN@L-A followed by SIGN@L-B, SIGN@L-B followed by SIGN@L-A

Primary outcome

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.
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.
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.
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.
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.
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.

5 secondary outcomes

Time spent playing with SIGN@L-A
Time frame: 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
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
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
Favorite prototype of the serious game
Time frame: Up to 14 days post-randomization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Derived from this study: PubMed 36729896Maheu-Cadotte MA, Dube V, Lavoie P. Development and Contribution of a Serious Game to Improve Nursing Students' Clinical Reasoning in Acute Heart Failure: A Multimethod Study. Comput Inform Nurs. 2023 Jun 1;41(6):410-420. doi: 10.1097/CIN.0000000000000966.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc-André Maheu-Cadotte, PhD(c) principal investigator

Université de Montréal

Patrick Lavoie, PhD study director

Université de Montréal

Véronique Dubé, PhD study director

Université de Montréal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SIGN@L-A and SIGN@L-B in people with Heart Failure and Motivation, run by Marc-André Maheu-Cadotte at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Engagement with SIGN@L-A (time frame: Up to a week after being assigned to SIGN@L-A). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04592432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.