Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409273
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-07
Brief Title:
Hybrid Course Assessment and Evaluation
Sponsor:
Research on Healthcare Performance Lab U1290
Organization:
Research on Healthcare Performance Lab U1290
Study Overview
Official Title:
Effect of Hybrid Versus Face-to-face Teaching on Course Assessment and Evaluation in Postgraduate General Practice Students a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOME
Brief Summary:
The academic training of French postgraduate students in general practice E3CMG is facing a challenge due to the increasing gap between the number of students and the available teaching hours To accommodate the growing number of students asynchronous acquisition of knowledge prior to a reduced face-to-face teaching would maintain the capacity to provide socio-constructivist teaching useful for developing problem-solving skills ie thesis design and feasibility assessment The main objective of this randomized controlled trial is to evaluate the effect of hybrid versus face-to-face socio-constructivist teaching on French E3CMG course assessment and evaluation
Detailed Description:
The E3CMG will be invited to attend one of the two teaching days in accordance with the usual university procedure They will be gathered in an amphitheater at the start of the teaching session 900 am where they will receive oral and written information about the study Blocked randomization with randomly selected block sizes will be performed among students who have signed a written consent to participate in the study Non-participants in the study will be assigned to one of the two teaching formats without randomization and respecting the need to achieve close class sizes Their teaching assessments will not be extracted and analyzed as part of the study
This late randomization procedure makes it possible to
allow students to change teaching day without regard to the study
avoid contamination bias caused by some students accessing the asynchronous interactive course before class
ensure compliance with the study protocol systematic access to the asynchronous interactive course by students in the intervention group
Control the time spent on the asynchronous interactive course to ensure that the time spent by students actually corresponds to that stated in the protocol
To limit missing data management procedures data collection on the day of teaching and randomization only of students present on the day of teaching limits attrition bias
The 4 teachers on the first teaching day will be randomly assigned to the groups May 14 If they take part in the second teaching day 0521 they will teach in the other group in order to minimize a bias in the evaluation of the main judgment criterion linked to teacher quality
The study begins on May 14 2024 or May 21 2024 depending on the participants assigned teaching day and ends on 11142024 The maximum duration of participation in the study is therefore 6 months The students actual participation is 1 day as data collection on 1411 is automated and does not require any intervention by the participant
No health data will be collected Data will be collected via a self-administered questionnaire with a randomized order of questions at the end of the teaching day and at 6 months via the universitys database of thesis forms
The number of participants to be included in the study is 72 per arm This is necessary to demonstrate a difference in the primary endpoint of 10 with a standard deviation of 4 points an alpha risk of 5 and a statistical power of 85 for a two-tailed t-test of comparison of observed means The theoretical maximum number of students included in the study was 83 per group allowing for a 13 refusal rate n22 students
A two-sided superiority test will be conducted with a multivariate analysis and sensitivity analysis To account for multiple comparisons regarding secondary objectives a fixed sequence procedure will be performed Once one hypothesis is tested and found to be not significantly different from the null hypothesis all subsequent tests and results will be considered as explanatory The secondary objectives described below are classified according to this procedure
This late randomization procedure makes it possible to
allow students to change teaching day without regard to the study
avoid contamination bias caused by some students accessing the asynchronous interactive course before class
ensure compliance with the study protocol systematic access to the asynchronous interactive course by students in the intervention group
Control the time spent on the asynchronous interactive course to ensure that the time spent by students actually corresponds to that stated in the protocol
To limit missing data management procedures data collection on the day of teaching and randomization only of students present on the day of teaching limits attrition bias
The 4 teachers on the first teaching day will be randomly assigned to the groups May 14 If they take part in the second teaching day 0521 they will teach in the other group in order to minimize a bias in the evaluation of the main judgment criterion linked to teacher quality
The study begins on May 14 2024 or May 21 2024 depending on the participants assigned teaching day and ends on 11142024 The maximum duration of participation in the study is therefore 6 months The students actual participation is 1 day as data collection on 1411 is automated and does not require any intervention by the participant
No health data will be collected Data will be collected via a self-administered questionnaire with a randomized order of questions at the end of the teaching day and at 6 months via the universitys database of thesis forms
The number of participants to be included in the study is 72 per arm This is necessary to demonstrate a difference in the primary endpoint of 10 with a standard deviation of 4 points an alpha risk of 5 and a statistical power of 85 for a two-tailed t-test of comparison of observed means The theoretical maximum number of students included in the study was 83 per group allowing for a 13 refusal rate n22 students
A two-sided superiority test will be conducted with a multivariate analysis and sensitivity analysis To account for multiple comparisons regarding secondary objectives a fixed sequence procedure will be performed Once one hypothesis is tested and found to be not significantly different from the null hypothesis all subsequent tests and results will be considered as explanatory The secondary objectives described below are classified according to this procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None