A Cross-over Randomised Trial Comparing Two Teaching Methods

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ClinicalTrials.gov Identifier: NCT04692142

Recruitment Status : Recruiting

First Posted : December 31, 2020

Last Update Posted : January 5, 2021

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Sponsor:

Information provided by (Responsible Party):

Prince Sattam Bin Abdulaziz University

Study Description

Brief Summary:

The aim of the study aim to test the null hypothesis which states that there are no significant differences in knowledge retention and exam performance of dental undergraduate students in a Saudi Dental School using two different asynchronous teaching methods . The secondary aim is to analyse students' perceptions to the two teaching methods.

Condition or disease	Intervention/treatment	Phase
Educational Problems	Other: Flipped classroom teaching method	Not Applicable

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Detailed Description:

Design: The trial is designed as a cross-over clustered randomized trial (each group would be a cluster), so that each group will act as their own control for their learning performance and perception.

Setting: School of Dentistry, Princes Sattam Bin Abdulaziz University/ Riyadh/ KSA.

Consents: Written consent will obtained from the students before commencing of the trail.

Participants: The cohort of the trial includes 33 fourth-year dental students that represents whole fourth-year undergraduate class in order to eliminate the selection bias.

Randomisation: Independent person will use computer-generated randomisation to allocate participants to one of the two groups. The sequence of random allocation will be concealed from the researchers who recruited the participants. Participants in the control group will be taught through the traditional passive online teaching model (PG) using live-video streaming while participants in the intervention arm (FG) will be taught through flipped the classroom model. Group 1 will consist of 16 students and group 2 will consist of 17 students.

Intervention A total of 4 lectures will be delivered asynchronously using two different teaching methods as mentioned above. Participants in FG will have a monitored remote access to the recorded lectures for one week followed by 4 additional small group online discussion sessions. The students in both groups will remotely attend all pre-recorded and live-video lectures.

Intervention implementation rounds The intervention will be implemented in 3 consecutive weeks The first lecture that will be taught in the first week will be related to the topic of Adult Orthodontics (L1).

Before L1, all students will be asked to complete a set of multiple-choice questions (MCQs), formative exam (i.e. pre-test). Following the test , the lecture will be delivered to the participants of PG using a passive online teaching format for 60 minutes (i.e., live-video streaming). After the lecture is completed, students will be asked to re-take the same pre-test exam and complete questionnaire regarding their experience with the teaching methods. Consent for recording L1 will be granted from the attendees before recording. Within 24 hours following L1, participants of FG will have an access to the recorded lecture.

and they will be taught using an active teaching model known as flipped classroom model. In this model, participants will have 7 -day monitored remote access to the recorded L1. Similar to PG, completing the online pre-test formative exam will be preliminary requirement to access the published recorded L1.

At the expiry of remote access to the recorded lecture, participants from FG will be invited to attend post-lecture discussion sessions. To enhance the effectiveness of flipped classroom teaching method, the cohort of FG will be randomly, using computer generated randomisation, subdivided to two smaller groups in which each group will be consisted of half of the FG cohort. The same lecturer will moderate the discussions for each group separately. After the lecture is completed, students will be asked to re-take the same pre-test of L1 and complete questionnaire regarding their experience with the teaching methods.

Following the small groups discussion session, participants of FG will be given a 30-minute break before the start of second lecture related to the topic of Orthognathic Surgery (L2). However, the intervention will be crossed over, hence, the cohort of FG in week 1 will act as a control group while teaching L2 and vice versa. The same protocol of teaching models that was applied in week 1 will be adopted.

Participants of both groups will be taught by the same instructor using the same materials, irrespective of the teaching methods. The lectures will be delivered using the same presentation platform (PowerPoint, Microsoft Corp, Redmond, WA) and the same virtual learning platform (Zoom live-streaming software - Zoom Video Communications, Inc, San Jose, California, Version 5.4.3). The duration of each lecture will be 60 minutes, while the post-lecture discussion, in the flipped classroom design, will take 15 minutes . Learning outcomes will be based on the learning objectives and outcomes of each lecture that align with what is specified by the National Commission for Academic Accreditation and Assessment in Saudi Arabia.

Formative MCQs exam Before each lecture, students will complete a set of multiple-choice questions (MCQs), formatively (i.e. pre-test). These questions will be related to the taught topics, and will be administered remotely using learning management system (Blackboard). After each lecture, students will be asked to re-take the same pre-test via Blackboard. This formative assessment test will measure students' learning gain. Two investigators will construct the pre-test questions to ensure its content validity and reliability. Content validity will be tested using test matrix and experts judgment. The reliability test will estimated using inter-rater reliability. A correlation of more than 0.7 will be considered acceptable.

Summative exam At the end of the semester, students will undertake their final summative written MCQ exam. This summative exam will cover topics taught during the second semester of preclinical orthodontic course. The summative written exam will include 10 randomly selected questions from bank of questions relevant to the orthodontic subjects taught in L1 and L2. The written exam questions will be identical for all students and will be delivered onsite, under controlled exam conditions. The summative written exam scores specific to L1 and L2 will be traced and collected using an Excel spreadsheet by an independent person, the scores will be anonymously coded to minimize reporting bias. The maximum achievable score for the questions relevant to the subjects taught in L1 and L2 will be in accordance with an exam blueprint specified for the course.

Students' perception At the end of each lecture, students will be asked to answer a questionnaire regarding their experience with the teaching methods they have received. We will use the validated Web-Based Learning Environment Inventory (WELEI). In addition to demographic section, the questionnaire consists of items that captures students' perceptions of web-based learning environments. Regarding the flipped classroom teaching method, additional questions adapted from previous studies that examined students' perception of the flipped classroom will be used. The questionnaire will be distributed online via SurveyMonkey (San Mateo, California, United States).

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	33 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Intervention Model Description:	The trial is designed as a cross-over clustered randomized trial (each group would be a cluster), so that each group will act as their own control for their learning performance and perception.
Masking:	Single (Outcomes Assessor)
Masking Description:	The outcomes assessor and the statistical analyst will be masked
Primary Purpose:	Other
Official Title:	Comparison Between Different Asynchronous Teaching Methods in an Undergraduate Orthodontic Course: A Crossover Randomised Trial
Actual Study Start Date :	August 30, 2020
Estimated Primary Completion Date :	April 30, 2021
Estimated Study Completion Date :	August 30, 2021

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Passive online Before L1, all students will be asked to complete a set of multiple-choice questions (MCQs), formative exam (i.e. pre-test). Following the test , the lecture will be delivered to the participants of PG using a passive online teaching format for 60 minutes (i.e., live-video streaming). After the lecture is completed, students will be asked to re-take the same pre-test exam and complete questionnaire regarding their experience with the teaching methods.	Other: Flipped classroom teaching method Participants will have 7 -day monitored remote access to a recorded lecture about orthodontic topic. At the expiry of remote access to the recorded lecture, participants from FG will be invited to attend post-lecture discussion sessions. To enhance the effectiveness of flipped classroom teaching method, the cohort of FG will be randomly, using computer generated randomisation, subdivided to two smaller groups in which each group will be consisted of half of the FG cohort. The same lecturer will moderate the discussions for each group separately.
Experimental: Flipped classroom Participants of FG will have an access to a recorded lecture. and they will be taught using an active teaching model known as flipped classroom model. In this model, participants will have 7 -day monitored remote access to the recorded L1. Similar to PG, completing the online pre-test formative exam will be preliminary requirement to access the published recorded L1. At the expiry of remote access to the recorded lecture, participants from FG will be invited to attend post-lecture discussion sessions. To enhance the effectiveness of flipped classroom teaching method, the cohort of FG will be randomly, using computer generated randomisation, subdivided to two smaller groups in which each group will be consisted of half of the FG cohort. The same lecturer will moderate the discussions for each group separately. After the lecture is completed, students will be asked to re-take the same pre-test of L1 and complete questionnaire regarding their experience with the teaching methods.	Other: Flipped classroom teaching method Participants will have 7 -day monitored remote access to a recorded lecture about orthodontic topic. At the expiry of remote access to the recorded lecture, participants from FG will be invited to attend post-lecture discussion sessions. To enhance the effectiveness of flipped classroom teaching method, the cohort of FG will be randomly, using computer generated randomisation, subdivided to two smaller groups in which each group will be consisted of half of the FG cohort. The same lecturer will moderate the discussions for each group separately.

Arm

Intervention/treatment

Active Comparator: Passive online

Other: Flipped classroom teaching method

Participants will have 7 -day monitored remote access to a recorded lecture about orthodontic topic. At the expiry of remote access to the recorded lecture, participants from FG will be invited to attend post-lecture discussion sessions. To enhance the effectiveness of flipped classroom teaching method, the cohort of FG will be randomly, using computer generated randomisation, subdivided to two smaller groups in which each group will be consisted of half of the FG cohort. The same lecturer will moderate the discussions for each group separately.

Experimental: Flipped classroom

Participants of FG will have an access to a recorded lecture. and they will be taught using an active teaching model known as flipped classroom model. In this model, participants will have 7 -day monitored remote access to the recorded L1. Similar to PG, completing the online pre-test formative exam will be preliminary requirement to access the published recorded L1.

Other: Flipped classroom teaching method

Outcome Measures

Primary Outcome Measures :

Formative exam [ Time Frame: 7-days ]
Before each lecture, students will complete a set of multiple-choice questions (MCQs), formatively (i.e. pre-test). These questions will be related to the taught topics, and will be administered remotely using learning management system (Blackboard). After each lecture, students will be asked to re-take the same pre-test via Blackboard. This formative assessment test will measure students' learning gain. Two investigators will construct the pre-test questions to ensure its content validity and reliability. Content validity will be tested using test matrix and experts judgment. The reliability test will estimated using inter-rater reliability. A correlation of more than 0.7 will be considered acceptable.

Secondary Outcome Measures :

Perception to the two teaching methods. [ Time Frame: 7-days ]
At the end of each lecture, students will be asked to answer a questionnaire regarding their experience with the teaching methods they have received. We will use the validated Web-Based Learning Environment Inventory (WELEI), developed by Chang and Fisher (2001). In addition to demographic section, the questionnaire consists of items that captures students' perceptions of web-based learning environments. Regarding the flipped classroom teaching method, we will include additional questions adapted from previous studies that examined students' perception of the flipped classroom (Johnson, 2013 and Butt, 2014). The questionnaire will be distributed online via SurveyMonkey (San Mateo, California, United States).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	22 Years to 28 Years (Adult)
Sexes Eligible for Study:	Male
Gender Based Eligibility:	Yes
Gender Eligibility Description:	The institution where the study will be carried on enrolls only male dental students.
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Fourth-year undergraduate students enrolled in the course, in a Saudi Dental college.

Exclusion Criteria:

Students who are enrolled in the course for a second time

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692142

Contacts

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Contact: AlWaleed Abushnan, MSc	00966500838933	a.abushanan@psau.edu.sa
Contact: Mohamed Almuzain, DDS	00447901740382	almuzian@gmail.com

Locations

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Saudi Arabia
Prince Sattam Bin Abdulaziz University	Recruiting
Al Kharjah, Saudi Arabia
Contact: AlWaleed Abushnan, MSc 966500838933 a.abushanan@psau.edu.sa
Sub-Investigator: Ali Alquraban, PhD

Sponsors and Collaborators

Prince Sattam Bin Abdulaziz University

Investigators

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Study Chair:	Fahad Alharbi, PhD	Prince Sattam Bin Abdulaziz University

More Information

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Responsible Party:	Prince Sattam Bin Abdulaziz University
ClinicalTrials.gov Identifier:	NCT04692142
Other Study ID Numbers:	PSAU2020030
First Posted:	December 31, 2020 Key Record Dates
Last Update Posted:	January 5, 2021
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Data will be shared upon asking.
Supporting Materials:	Study Protocol
Time Frame:	Within one year
Access Criteria:	Eligible researcher who does a similar research.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Prince Sattam Bin Abdulaziz University:


Learning Dental education Teaching methods Dental Students

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