Academic PerformanceNCT04864756
Simulation Based Learning and Academic Performance in Medical School
A study testing Simulation based learning in people with Academic Performance, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial summary
The investigators will use a multi-methods approach, including both qualitative and quantitative methods. In the quantitative methodology, the investigators will use a before and after approach to compare medical student grades/scores before and after the integration of Simulation based learning (SBL) in the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Academic Performance
- What is being tested?
- Simulation based learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jun 2019to 30 Dec 2022
- 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
- Medical (Medicine and Nursing) students
- Enrolled in the Faculty of medicine at Mbarara University of Science and Technology
- Currently attending clinical years
Who cannot join
- Non clinical student years in the Faculty of Medicine
- not enrolled in Medicine or Nursing programs at Mbarara University of Science and Technology
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mbarara University of Science and Technology
Mbarara, 256
Data Santorino, MD, 0774500571, sdata@must.ac.ug
About this study
Official title: Medical Simulation Teaching and Academic Performance Among Medical Students at a Medical School in Rural Uganda
The investigators will use a multi-methods approach, including both qualitative and quantitative methods. In the quantitative methodology, the investigators will use a before and after approach to compare medical student grades/scores before and after the integration of Simulation based learning (SBL) in the curriculum. The hypothesis is that SBL will generally increase knowledge and skills and hence improve the scores from the theory (MCQ) and clinical (OSCE) examinations conducted outside simulated settings in the clinical departments.
Read the detailed description
Simulation faculty development will be measured by retention and engagement in simulation sessions. The investigators will use survival analysis methods and plot Kaplan Meier curves to calculate probability of retention and determine the factors that are associated with retention as derived from participant in-depth interviews and departmental meetings. A faculty member will be considered disengaged if they do not participate in simulation session for at least 6 months post training, despite reminders and opportunities for participation. Reasons for potential disengagement will be explored qualitatively.
In the qualitative approach, the investigators will conduct in-depth key informant interviews (45 minutes to 1 hour) with administrators at the institution, namely Academic Registrar, Deans of Medical School, heads of Departments and Simulation facilitators (the post-graduate student trainers). The investigators will conduct focus group discussions (1 hour) with postgraduate simulation facilitators, the medical and nursing students before, during and after their enrollment in SBL. The interviews and focus group discussions will be audio-recorded and transcribed.
- Conditions
- Academic Performance
- Being tested
- Simulation based learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation based learningOther
Learning for medical students using simulation based techniques including scenario execution as a complement to conventional teaching methodologies
| Study group | Role | What they receive |
|---|---|---|
| Before/After | Experimental | Grade performance before and after introduction of simulation based learning Receives: Other: Simulation based learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic performance
Change in CGPA scores Before and after introduction of simulation based techniques
Measured: 36 months after introduction of simulation based techniques
Secondary outcomes (1)
Retention of academic faculty
Percentage of faculty retained in the training program
Measured: 2 years after initiation of simulation based learning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Jun 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Academic PerformanceStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after comparison
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Alberta Children's Hospital Research Institute, The ELMA Foundation, Laerdal Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864756
- Sponsor's protocol ID
- 2020/MUST/SIM-II
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will share with permission from the research ethics committee and Mbarara University Academic Registrar's authorization
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Simulation Teaching and Academic Performance Among Medical Students at a Medical School in Rural Uganda
- ClinicalTrials.gov ID
- NCT04864756
- Acronym / sponsor ID
- 2020/MUST/SIM-II
- Conditions
- Academic Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Calgary, Alberta Children's Hospital Research Institute, The ELMA Foundation, Laerdal Foundation
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Apr 2021 (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.
The investigators will use a multi-methods approach, including both qualitative and quantitative methods. In the quantitative methodology, the investigators will use a before and after approach to compare medical student grades/scores before and after the integration of Simulation based learning (SBL) in the curriculum. The hypothesis is that SBL will generally increase knowledge and skills and hence improve the scores from the theory (MCQ) and clinical (OSCE) examinations conducted outside simulated settings in the clinical departments.
Detailed description
Simulation faculty development will be measured by retention and engagement in simulation sessions. The investigators will use survival analysis methods and plot Kaplan Meier curves to calculate probability of retention and determine the factors that are associated with retention as derived from participant in-depth interviews and departmental meetings. A faculty member will be considered disengaged if they do not participate in simulation session for at least 6 months post training, despite reminders and opportunities for participation. Reasons for potential disengagement will be explored qualitatively.
In the qualitative approach, the investigators will conduct in-depth key informant interviews (45 minutes to 1 hour) with administrators at the institution, namely Academic Registrar, Deans of Medical School, heads of Departments and Simulation facilitators (the post-graduate student trainers). The investigators will conduct focus group discussions (1 hour) with postgraduate simulation facilitators, the medical and nursing students before, during and after their enrollment in SBL. The interviews and focus group discussions will be audio-recorded and transcribed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after comparison
| Arm | Type | Receives |
|---|---|---|
| Before/After | Experimental | Other: Simulation based learningGrade performance before and after introduction of simulation based learning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical (Medicine and Nursing) students
- Enrolled in the Faculty of medicine at Mbarara University of Science and Technology
- Currently attending clinical years
Key exclusion criteria (2 listed)
- Non clinical student years in the Faculty of Medicine
- not enrolled in Medicine or Nursing programs at Mbarara University of Science and Technology
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 |
|---|---|---|
| Simulation based learningLearning for medical students using simulation based techniques including scenario execution as a complement to conventional teaching methodologies | Other | Before/After |
Primary outcome
Academic performance
Time frame: 36 months after introduction of simulation based techniques
Change in CGPA scores Before and after introduction of simulation based techniques
1 secondary outcome
Retention of academic faculty
Time frame: 2 years after initiation of simulation based learning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: Yes. Data will share with permission from the research ethics committee and Mbarara University Academic Registrar's authorization
Related trials for Academic Performance
Not yet recruitingObservational study
Lifestyle Behaviors and Their Associations With Mental Health, Aggressive Behaviors and Academic Performance Among Assiut University Students
Lifestyle Behaviors
Not yet recruiting
The Effect of Audio-hypnosis on the Academic Performance of Nursing Students.
Age, Residency
Enrolling by invitation
Virtual Reality-Supported Relaxation Before Objective Structured Clinical Examination
Virtual Reality
Recruiting
Taabo Tutoring Study
Secondary School Entry and Completion, Education Advancement
Not yet recruiting
Acute Effects of Active Breaks and Physically Active Learning in University Students
Cognitive Performance, Academic Performance
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation based learning in people with Academic Performance, run by Mbarara University of Science and Technology at 1 site in Uganda.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 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 Uganda. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Data Santorino, MD (0774500571, sdata@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Academic performance (time frame: 36 months after introduction of simulation based techniques). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2021.