Plain English Summary
Background and study aims
The World Health Organization (WHO) has recognised antimicrobial resistance (AMR) as one of the greatest threat to human health. WHO defined AMR as the potential of microorganisms to gain the ability to resist antimicrobial agents. This study aims to assess the effectiveness of an online module about AMR on the knowledge of this topic among dental students.
Who can participate?
Dental students from Umm Al-Qura University
What does the study involve?
Participants will be randomly allocated to either the study group or the control group. Participants in the study group will receive a 9 minute online course providing information about AMR. The control group will receive a 5 minute online course regarding the microorganisms and normal flora of the oral cavity, with no information about AMR. All participants will be asked to complete the same questionnaire before the course, immediately after the course and then again after 2 months.
What are the possible benefits and risks of participating?
The possible benefit of participating is that this study may help the community to become more aware of antimicrobial drugs, their misuse and the consequences of this. Participants will also be entered into a prize draw for a 200 SR bookstore voucher. There are no known risks to participants taking part in this study.
Where is the study run from?
Umm Al-Qura University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
October 2017 to April 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Khalid Aboalshamat
ktaboalshamat@uqu.edu.sa
Trial website
Contact information
Type
Scientific
Primary contact
Dr Khalid Aboalshamat
ORCID ID
http://orcid.org/0000-0001-5957-8681
Contact details
-
Makkah
21955
Saudi Arabia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
77-17
Study information
Scientific title
The effectiveness of an online course intervention to improve the knowledge of antimicrobial resistance among dental students in comparison to a placebo intervention
Acronym
Superbug
Study hypothesis
Are there any benefits from using online modules to enhance the knowledge of antimicrobial resistance among dental students?
Ethics approval
Umm Al-Qura University Faculty of Dentistry, 20/12/2017, ref: 77-17
Study design
Interventional triple-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Knowledge of antimicrobial resistance
Intervention
The students were randomised into the study group or to the active control group. Students in the study group, received a link on their mobile phone to the study consent form and baseline questionnaire (T1), which then followed on to the intervention online course. This online course consisted of auto played 35 slides with an accompanying audio for nine minutes. The course explained definition of antimicrobial resistance (AMR), types of antibiotic action, how AMR develops, causes of AMR, the role of dentists in reducing AMR, and when to prescribe an antibiotic as a dentist. After this, the participants were asked to answer the post intervention questionnaire (T2). The participants were followed up with the same questionnaire after one month of the intervention (T3). Each questionnaire took approximately 10-15 minutes. The intervention was not tailored to participants individually. However, the participants were free to take the intervention at their free time during the day of the intervention. The intervention online course information was derived from previous validated governmental and scientific references, and then confirmed by dental consultants.
The participants in the active control group followed the same process, but they received a different course composed of 34 slides given in 5 minutes. This contained information about microorganisms in dentistry, including the definition of normal flora, types of normal flora, common habitats of human microbial flora, changes of the oral flora throughout life, the benefit of resident flora, disadvantages of the oral flora and factors modulating growth of bacteria in the oral cavity. Information about AMR was not included in the online course for this group.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Knowledge of dental students about antimicrobial resistance, assessed using the study questionnaires at the baseline, end of the intervention and at the 2 month follow-up. Changes in this will be assessed from:
1. T1 to T2 (baseline to end of the intervention)
2. T2 to T3 (end of the intervention to 2 month follow-up)
3. T1 to T3 (baseline to 2 month follow-up)
Secondary outcome measures
N/A
Overall trial start date
02/10/2017
Overall trial end date
21/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Students of Umm Al-Qura University
2. Dental students (4th, 5th, and 6th years)
3. Submitted an online informed consent to participate in the study
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
200
Total final enrolment
64
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
15/01/2018
Recruitment end date
20/01/2018
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Umm Al-Qura University
Makkah
21955
Saudi Arabia
Sponsor information
Organisation
Umm Al-Qura University
Sponsor details
-
Makkah
21955
Saudi Arabia
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We aim to publish the study result in one publication as soon as we finish the study.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available, as the data can be verified for only validity purposes if required by an authority has the right to check our result upon request from the main author Dr. Khalid Aboalshamat. The data is quantitative data and will be stored in Dr. Khalid Aboalshamat's office in Umm Al-Qura University for two years. The data can be accessed by the research team only. All data was taken from the participants after signing an electronic consent to use their data for the purpose of this study only.
Intention to publish date
01/01/2020
Participant level data
Not expected to be available
Basic results (scientific)
See additional file (ISRCTN13442659_BasicResults_16Oct2018)
Publication list
2019 results in https://doi.org/10.3889/oamjms.2019.723 (added 06/07/2020)
Publication citations
Additional files
- ISRCTN13442659_BasicResults_16Oct2018.pdf uploaded 24/04/2019