LeprosyNCT02484469
Impact of the Virtual Human Project on Team-based Learning: A Randomized-controlled Trial
A study testing The Virtual Human Project in people with Leprosy, run by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior..
Trial summary
Team-based learning (TBL) is a learner-centered, instructor-directed strategy for small group active learning in large group educational settings. When TBL is conducted correctly, the students' performances are equivalent or improved in comparison to either lecture-based formats or more traditional small group… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leprosy
- What is being tested?
- The Virtual Human Project
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Mar 2015
- 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
- undergraduate medical students in the third year of Medical School at the Federal University of Mato Grosso do Sul.
Who cannot join
- students previously exposed to dermatologic research, extracurricular activities involving dermatology or dermatology rotation in that year
About this study
Official title: Educational Virtual Objects (The Virtual Human Project) Assessment Inserted in Learning Based on Team (Team-based Learning) in Leprosy Education on Undergraduate Medical Setting
Team-based learning (TBL) is a learner-centered, instructor-directed strategy for small group active learning in large group educational settings. When TBL is conducted correctly, the students' performances are equivalent or improved in comparison to either lecture-based formats or more traditional small group learning models.1 Nevertheless, few studies have been published regarding the insertion of innovative audiovisual tools in the TBL context. The Virtual Human Project is described as powerful sequences of three dimension (3D) computer graphics video of the human body that aids learning by facilitating an understanding in relation to a specific subject. The Virtual Human is composed by video sequences combining anatomy, physiology, and morphology in the context of various diseases. There are video sequences available for many disciplines, including dermatology and with capacity to produce anatomical structures by 3D printer. Despite the incredible potential applications of the Virtual Human, few studies have assessed its impact on medical education. The investigators did not find any study evaluating TBL with the insertion of iconographic educational material that assessed whether this intervention could change the learning progress of students. This is the aim of the present study, by comparing students tests scores after a TBL session with the VIrtual Human videos about leprosy or a standard TBL session, and to evaluate the student's satisfaction with the Virtual Human videos.
- Conditions
- Leprosy
- Being tested
- The Virtual Human Project
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Virtual Human ProjectDevice
Virtual Human educational videos about leprosy
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Experimental | The Virtual Human Project videos and Team-Based learning session about leprosy Receives: Device: The Virtual Human Project |
| Unexposed | Placebo comparator | Standard Team-Based learning session about leprosy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of Individual readiness assessment test (IRAT) grades
The average of the IRAT scores achieved by students
Measured: One year
Secondary outcomes (2)
The Average of group readiness assessment test (GRAT) grades
The average of the GRAT scores achieved by students
Measured: One year
The Average of clinical case scores
The average of the clinical case scores achieved by students
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cristiane Comparin, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484469
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2015
- First submitted
- 25 Jun 2015
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Virtual Objects (The Virtual Human Project) Assessment Inserted in Learning Based on Team (Team-based Learning) in Leprosy Education on Undergraduate Medical Setting
- ClinicalTrials.gov ID
- NCT02484469
- Acronym / sponsor ID
- 001
- Conditions
- Leprosy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.Other government
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jun 2015 (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.
Team-based learning (TBL) is a learner-centered, instructor-directed strategy for small group active learning in large group educational settings. When TBL is conducted correctly, the students' performances are equivalent or improved in comparison to either lecture-based formats or more traditional small group learning models.1 Nevertheless, few studies have been published regarding the insertion of innovative audiovisual tools in the TBL context. The Virtual Human Project is described as powerful sequences of three dimension (3D) computer graphics video of the human body that aids learning by facilitating an understanding in relation to a specific subject. The Virtual Human is composed by video sequences combining anatomy, physiology, and morphology in the context of various diseases. There are video sequences available for many disciplines, including dermatology and with capacity to produce anatomical structures by 3D printer. Despite the incredible potential applications of the Virtual Human, few studies have assessed its impact on medical education. The investigators did not find any study evaluating TBL with the insertion of iconographic educational material that assessed whether this intervention could change the learning progress of students. This is the aim of the present study, by comparing students tests scores after a TBL session with the VIrtual Human videos about leprosy or a standard TBL session, and to evaluate the student's satisfaction with the Virtual Human videos.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | Experimental | Device: The Virtual Human ProjectThe Virtual Human Project videos and Team-Based learning session about leprosy |
| Unexposed | Placebo comparator | –Standard Team-Based learning session about leprosy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergraduate medical students in the third year of Medical School at the Federal University of Mato Grosso do Sul.
Key exclusion criteria (1 listed)
- students previously exposed to dermatologic research, extracurricular activities involving dermatology or dermatology rotation in that year
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 |
|---|---|---|
| The Virtual Human ProjectVirtual Human educational videos about leprosy | Device | Exposed |
Primary outcome
Average of Individual readiness assessment test (IRAT) grades
Time frame: One year
The average of the IRAT scores achieved by students
2 secondary outcomes
The Average of group readiness assessment test (GRAT) grades
Time frame: One year
The Average of clinical case scores
Time frame: One year
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 29 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Virtual Human Project in people with Leprosy, run by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior..
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 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Average of Individual readiness assessment test (IRAT) grades (time frame: One year). 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 Jun 2015.