Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000432516
Ethics application status
Approved
Date submitted
3/01/2024
Date registered
9/04/2024
Date last updated
9/04/2024
Date data sharing statement initially provided
9/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and Effectiveness of Rabies Health Education Module (RaHEM) for Dog Owners in Kelantan
Scientific title
Development and Effectiveness of Rabies Health Education Module (RaHEM) for Dog Owners in Kelantan: A Randomized Control Trial
Secondary ID [1] 311205 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rabies 332473 0
Condition category
Condition code
Public Health 329169 329169 0 0
Health promotion/education
Infection 329767 329767 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rabies Health Education Module Mass Open Online Course (RaHEM MOOC). This online course comprises in-depth modules covering various facets of rabies, including prevention strategies, and recognizing symptoms. Participants will have access to a rich array of digital resources such as informative videos and engaging infographics. Interactive quizzes and assessments will be integrated to reinforce learning. The course will be delivered by experienced medical doctors, veterinarians, and public health professionals with a minimum of 5 years' relevant experience. This module is spread over 5 topics spanning over 11 sub-topics. The module will cover various topics, including an overview of rabies (Rabies in general, Rabies in Human, Canine Rabies), human rabies prevention (Dog Bite, Post Exposure Prophylaxis, The do & don’ts), human-dog interaction (Dog’s behaviour, dog-bite prevention), dog welfare (responsible pet ownership), and canine rabies prevention (vaccination, mythology & misconception). The RaHEM MOOC provides a wealth of digital resources carefully crafted for this study, including informative videos, engaging infographics, and interactive quizzes. These resources aim to enhance learning and reinforce key concepts effectively.

Participants can navigate through the course material at their own pace, with each topic expected to be completed within 30-45 minutes, culminating in a total duration of 4-5 hours for the entire module. Accessible anytime, anywhere with an internet connection, this self-paced course offers unparalleled flexibility, allowing participants to engage with the content according to their convenience. Throughout the intervention period, which spans one month, participants will have continuous access to the course, enabling them to absorb the material thoroughly and apply it in real-world scenarios. The digital resources accompanying the RaHEM MOOC have been meticulously crafted and tailored specifically for this study. To ensure adherence to the intervention, the USM MOOC platform will track participants' progress, providing valuable insights for the research team. Additionally, proactive measures such as follow-up calls will be implemented to support and encourage participants in their learning journey.
Intervention code [1] 327711 0
Prevention
Intervention code [2] 328097 0
Lifestyle
Comparator / control treatment
The control group received the "Guideline for Diagnosis, Treatment, and Endoparasite Control in Dogs" as a PDF e-book. Instructions were given in written format, along with a link for accessing the e-books. Adherence to the control treatment was tracked by confirming receipt of the e-books, which was an extra advantage for participants as dog owners. This PDF e-book can be easily found on the official website of the Tropical Council for Companion Animal Parasites Ltd. (https://www.troccap.com/canine-guidelines).
Control group
Placebo

Outcomes
Primary outcome [1] 337012 0
Knowledge
Timepoint [1] 337012 0
Baseline (either pre-intervention), and final assessment (either one month after the completion of the intervention or one month after recruitment for the control group)
Primary outcome [2] 337013 0
Attitude
Timepoint [2] 337013 0
Baseline (pre-intervention), and final assessment (either one month after the completion of the intervention or one month after recruitment for the control group)
Secondary outcome [1] 430355 0
Nil
Timepoint [1] 430355 0
Nil

Eligibility
Key inclusion criteria
Individual aged 18 and above, owned at least one dog at home and has a good coverage of internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who unable to understand either English or Malay language fluent or already participate in phase II validation study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple block of four randomisation by an online randomisation service by Sealed Envelope Ltd 2022.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
one-way MANOVA

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/12/2023
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
80
Accrual to date
70
Final
Recruitment outside Australia
Country [1] 26061 0
Malaysia
State/province [1] 26061 0
Kelantan

Funding & Sponsors
Funding source category [1] 315514 0
Other Collaborative groups
Name [1] 315514 0
Southeast Asia One Health University Network (SEAOHUN)
Country [1] 315514 0
Thailand
Primary sponsor type
Individual
Name
MOHAMMAD FAZRUL BIN MOHAMMAD BASIR
Address
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 317534 0
Individual
Name [1] 317534 0
SUHAILY BINTI MOHD HAIRON
Address [1] 317534 0
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia
Country [1] 317534 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314373 0
Human Research Ethics Committee Universiti Sains Malaysia
Ethics committee address [1] 314373 0
Division of Research & Innovation (R&I), USM Health Campus, 16150, Kubang Kerian, Kelantan.
Ethics committee country [1] 314373 0
Malaysia
Date submitted for ethics approval [1] 314373 0
04/01/2023
Approval date [1] 314373 0
30/04/2023
Ethics approval number [1] 314373 0
USM/JEPeM/KK/23010060

Summary
Brief summary
This phase of study design utilized open-labelled randomized control trial to establish the effectiveness of Rabies Health Education Module (RaHEM) using pre- and post-design. Newly developed RaHEM will be introduce to intervention group and assessment on knowledge and attitude using CA-ZDQ questionnaire at one month post intervention will be conducted. Comparison of knowledge and attitude score between intervention (RaHEM) and control group at one-month by using MANOVA statistical analysis. The study's hypothesis is that Rabies Health Education Module (RaHEM) for Dog Owners significantly improving knowledge and attitude score in intervention group at one-month post intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131346 0
Dr MOHAMMAD FAZRUL BIN MOHAMMAD BASIR
Address 131346 0
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia
Country 131346 0
Malaysia
Phone 131346 0
+601111052990
Fax 131346 0
Email 131346 0
drfazrul@student.usm.my
Contact person for public queries
Name 131347 0
Dr MOHAMMAD FAZRUL BIN MOHAMMAD BASIR
Address 131347 0
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia
Country 131347 0
Malaysia
Phone 131347 0
+601111052990
Fax 131347 0
Email 131347 0
drfazrul@student.usm.my
Contact person for scientific queries
Name 131348 0
Dr MOHAMMAD FAZRUL BIN MOHAMMAD BASIR
Address 131348 0
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia
Country 131348 0
Malaysia
Phone 131348 0
+601111052990
Fax 131348 0
Email 131348 0
drfazrul@student.usm.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.