Condition category
Not Applicable
Date applied
07/10/2018
Date assigned
25/10/2018
Last edited
06/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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

www.uqu.edu.sa

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

Editorial Notes

06/07/2020: Publication reference added. 24/04/2019: The basic results of this trial have been uploaded as an additional file. 23/04/2019: The following changes have been made: 1. The total final enrolment has been added. 2. The intention to publish date has been changed from 01/01/2019 to 01/01/2020. 02/11/2018: Internal review.