AsthmaPhase 1SimAGNCT02776358
HFS in the Assessement and Management of Severe Asthma Attack Among Fifth Year Medical School Students
A Phase 1 study testing High Fidelity Simulation and Video case in people with Asthma, run by University of Monastir at 1 site in Tunisia.
Trial summary
Bedside clinical case learning, such for respiratory distress, represent a challenge for medical teachers, especially in critical conditions. In fact, this kind of learning implicate the presence of an appropriate case (the patient itself), framework and may be time consuming which could compromise the patient's… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- High Fidelity Simulation and Video case
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTunisia
- Study dates
- Sep 2014to May 2015
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all fifth year medical students allocated to the one month internship period in the emergency departement.
Who cannot join
- students refusing to participate in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Fidelity Simulation (HFS) Versus Video-case(VC) Trainings in the Assessement and Management of Severe Asthma Attack Among Medical School Students: a Randomized Controlled Study
Bedside clinical case learning, such for respiratory distress, represent a challenge for medical teachers, especially in critical conditions. In fact, this kind of learning implicate the presence of an appropriate case (the patient itself), framework and may be time consuming which could compromise the patient's safety and wellbeing.
New pedagogic tools have emerged to strengthen the medical reasoning and the acquisition of knowledge. in recent years, the development of medical simulation has found a growing interest in the medical teaching field. Contextualization, reproducibility and reliability are the characteristics of high-fidelity simulation (HFS) which guarantee a lifetime experience of clinical conditions without putting at risk patient's safety and comfort.
The aim of this study is to assess the impact of HFS on fifth year medical students learning skills in the assessement and management of an acute asthma attack in the emergency room, and to compares it to other modern teaching tools such as "video-case"
- Conditions
- Asthma
- Being tested
- High Fidelity Simulation, Video case
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fidelity SimulationOther
A HFS session for an asthma attack require:
- a 5 minutes briefing session: case and equipments presentation and choice of participants
- 15 minutes of actual simulation
- 40 minutes of debriefing
A pre and a post test will be taken by the students before and after the session and a satisfaction questionnaire at the end of the course.
Also, another test will be done after 7 days of the course.
Video caseOther
a video case (or video box) session in which students will attend a video-projection of a real case of an asthma attack and discuss with the trainer the different steps of the assessement and management of an asthma attack.
A pre and a post test will be taken by the students before and after the session and a satisfaction questionnaire at the end of the course.
Also, another test will be done after 7 days of the course.
| Study group | Role | What they receive |
|---|---|---|
| High Fidelity Simulation | Experimental | Students will receive a 1 hour High fidelity simulation session Receives: Other: High Fidelity Simulation |
| Video Case | Experimental | Students will receive a 1 hour assisted Video Case learning session Receives: Other: Video case |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the pre and the post-test scores in each group (delta Score)
The difference between the pre and the post-test scores is calculated as follow:
delta score = post-test score - pre-test score
Measured: Just before the teaching course (baseline) and one hour later
Secondary outcomes (2)
Late performance score
This score is calculated based on a test taken 7 days after the teaching course to assess the students memory of the clinical case and acquired knowledge.
Measured: 7 days after the teaching course
Level of satisfaction
A five point likert scale is given to each student to assess their level of satisfaction regarding the teaching technique.
Measured: one hour after the teaching course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
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 AsthmaStudies 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 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Mohamed habib Grissa, MD, Principal investigator, Emergency Department , university hospital of Monastir, TUNISIANouira Semir, Professor, Principal investigator, Emergency Department , university hospital of Monastir, TUNISIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776358
- Sponsor's protocol ID
- SimAG
- Acronym
- SimAG
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Grissa MH, Dhaoui R, Bel Haj Ali K, Sekma A, Toumia M, Sassi S, Sakly AK, Zorgati A, Bouraoui H, Ben Soltane H, Mezgar Z, Boukef R, Boubaker H, Bouida W, Beltaief K, Nouira S. Comparison of simulation and video-based training for acute asthma. BMC Med Educ. 2023 Nov 16;23(1):873. doi: 10.1186/s12909-023-04836-7.
PubMed 37974223
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Fidelity Simulation (HFS) Versus Video-case(VC) Trainings in the Assessement and Management of Severe Asthma Attack Among Medical School Students: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02776358
- Acronym / sponsor ID
- SimAG / SimAG
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 May 2016 (estimated)
- 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.
Bedside clinical case learning, such for respiratory distress, represent a challenge for medical teachers, especially in critical conditions. In fact, this kind of learning implicate the presence of an appropriate case (the patient itself), framework and may be time consuming which could compromise the patient's safety and wellbeing.
New pedagogic tools have emerged to strengthen the medical reasoning and the acquisition of knowledge. in recent years, the development of medical simulation has found a growing interest in the medical teaching field. Contextualization, reproducibility and reliability are the characteristics of high-fidelity simulation (HFS) which guarantee a lifetime experience of clinical conditions without putting at risk patient's safety and comfort.
The aim of this study is to assess the impact of HFS on fifth year medical students learning skills in the assessement and management of an acute asthma attack in the emergency room, and to compares it to other modern teaching tools such as "video-case"
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fidelity Simulation | Experimental | Other: High Fidelity SimulationStudents will receive a 1 hour High fidelity simulation session |
| Video Case | Experimental | Other: Video caseStudents will receive a 1 hour assisted Video Case learning session |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all fifth year medical students allocated to the one month internship period in the emergency departement.
Key exclusion criteria (1 listed)
- students refusing to participate in the protocol.
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 |
|---|---|---|
| High Fidelity SimulationA HFS session for an asthma attack require: * a 5 minutes briefing session: case and equipments presentation and choice of participants * 15 minutes of actual simulation * 40 minutes of debriefing A pre and a post test will be taken by the students before and after the session and a satisfaction questionnaire at the end of the course. Also, another test will be done after 7 days of the course. | Other | High Fidelity Simulation |
| Video casea video case (or video box) session in which students will attend a video-projection of a real case of an asthma attack and discuss with the trainer the different steps of the assessement and management of an asthma attack. A pre and a post test will be taken by the students before and after the session and a satisfaction questionnaire at the end of the course. Also, another test will be done after 7 days of the course. | Other | Video Case |
Primary outcome
Difference between the pre and the post-test scores in each group (delta Score)
Time frame: Just before the teaching course (baseline) and one hour later
The difference between the pre and the post-test scores is calculated as follow: delta score = post-test score - pre-test score
2 secondary outcomes
Late performance score
Time frame: 7 days after the teaching course
Level of satisfaction
Time frame: one hour after the teaching course
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 18 May 2016.
- Derived from this study: PubMed 37974223Grissa MH, Dhaoui R, Bel Haj Ali K, Sekma A, Toumia M, Sassi S, Sakly AK, Zorgati A, Bouraoui H, Ben Soltane H, Mezgar Z, Boukef R, Boubaker H, Bouida W, Beltaief K, Nouira S. Comparison of simulation and video-based training for acute asthma. BMC Med Educ. 2023 Nov 16;23(1):873. doi: 10.1186/s12909-023-04836-7.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed habib Grissa, MD principal investigator
Emergency Department , university hospital of Monastir, TUNISIA
Nouira Semir, Professor principal investigator
Emergency Department , university hospital of Monastir, TUNISIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High Fidelity Simulation and Video case in people with Asthma, run by University of Monastir at 1 site in Tunisia.
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 18 May 2016. 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 Tunisia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference between the pre and the post-test scores in each group (delta Score) (time frame: Just before the teaching course (baseline) and one hour later). 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 NCT02776358, 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 18 May 2016.