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Trial registered on ANZCTR


Registration number
ACTRN12619000217101
Ethics application status
Approved
Date submitted
30/01/2019
Date registered
14/02/2019
Date last updated
19/08/2019
Date data sharing statement initially provided
14/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and evaluation of effective health education module against respiratory tract infections among Malaysian Hajj pilgrims
Scientific title
Development and evaluation of effective health education module against respiratory tract infections among Malaysian Hajj pilgrims
Secondary ID [1] 297228 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory tract infection 311290 0
Condition category
Condition code
Public Health 309903 309903 0 0
Health promotion/education
Infection 309938 309938 0 0
Other infectious diseases
Respiratory 310080 310080 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is the Hajj Health education module for the prevention of respiratory tract infections via smartphone applications and printed booklets specifically designed for study. The name of the intervention application is "Hajj Health Education Module". It is available in the google playstore by searching the keywords "Hajj HEM". The application intervention is developed and designed as self-learning module that can be downloaded from google playstore and operated by the user continuously at any time. They are presented by the researcher to the pilgrims in the intervention during Hajj orientation course organized by the private Hajj company. The splash screen of the smartphone application is projected on powerpoint to the group of participants at the beginning of the 2-days course to download. The application intervention is produced to provide details of the preventive practices as recommended by the WHO and CDC. Compliance of the application by the user will be tracked through formative assessment. The content of the application was summarized into a booklet to cover preventive practices towards respiratory tract infections before departure to Hajj, during Hajj pilgrimage and after returning to home country from Hajj. The intervention covers areas such as the mandatory and recommended vaccines, the use of facemask, proper hand hygiene, cough etiquette, social distancing and crowd avoidance. Two private Hajj companies were selected based on the high number of customers that are more than our required sample size. One company will serve as the intervention and the other company as the control group. Participants were asked for informed consent and invited to participate in the study.
Intervention code [1] 313481 0
Prevention
Intervention code [2] 313482 0
Treatment: Other
Comparator / control treatment
"Jelajah Maya Madinah" a smartphone application on normal hajj guide developed by Universiti Sains Malaysia (USM) available on google play store
Control group
Active

Outcomes
Primary outcome [1] 318858 0
Pilgrim's total knowledge score will be assessed by knowledge, attitude and practice questionnaire towards the prevention of respiratory tract infection that will be developed and validated for this study
Timepoint [1] 318858 0
Single time assessment From day 1 to day 7 after return from Hajj
Primary outcome [2] 318985 0
pilgrims' total attitude score will be assessed by knowledge, attitude and practice questionnaire towards the prevention of respiratory tract infection that will be developed and validated for this study
Timepoint [2] 318985 0
single time within 7 days after return from Hajj
Primary outcome [3] 318986 0
Total practice score will be assessed by knowledge, attitude and practice questionnaire towards the prevention of respiratory tract infection that will be developed and validated for this study
Timepoint [3] 318986 0
Single time within 7 days after return from Hajj
Secondary outcome [1] 366276 0
Laboratory confirmed respiratory virus infection. On return from Hajj, Nasopharyngeal swab for reverse transcriptase polymerase chain reaction (RT-PCR) analysis for respiratory virus infection will be taken and immediately transported to the laboratory
Timepoint [1] 366276 0
Single time from day 1 to day 7 after return from Hajj

Eligibility
Key inclusion criteria
Malaysia Hajj pilgrims traveling through private Hajj companies.

Smartphone users.

Both gender, aged 18 and above
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hajj pilgrims through Government agency.

Children less than 16 years.

None smartphone users.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
1. Two means formula will be applied to determine the required minimum sample size for each group based on KAP scores. The expected detectable difference of KAP scores according to time will be determined based on expert opinion and standard deviation (SD) will be obtained from the literature. The expected drop-out of 10% will be included in the final sample size. It will be redetermined after pilot study
2. Two means formula will be applied to determine the required minimum sample size for each group based on respiratory infection scores. The expected detectable difference of respiratory tract infection scores will be determined based on expert opinion and standard deviation (SD) will be obtained from the literature. The expected drop-out of 10% will be included in the final sample size. It will be predetermined.
3. Two proportions formula will be applied to determine the required minimum sample size for each group based on proportions of colonization positivity. The proportion of colonization positivity in the intervention group (P1) will be determined based on expert opinion and that of the control group (P0) will be obtained from the literature. The expected drop-out of 10% will be included in the final sample size.
4. Repeated measures ANCOVA will be applied to compare KAP scores within and between intervention and control groups based on time.
5. Analysis of Covariance will be applied to compare respiratory tract infection symptoms scores between intervention and control groups
6. Multiple logistic regression analysis will be applied to compare the proportions of positivity of nasopharyngeal swab colonization among the influenza viruses

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/02/2018
Date of last participant enrolment
Anticipated
16/02/2019
Actual
12/05/2019
Date of last data collection
Anticipated
23/02/2019
Actual
31/05/2019
Sample size
Target
240
Accrual to date
Final
240
Recruitment outside Australia
Country [1] 21228 0
Malaysia
State/province [1] 21228 0
Kelantan

Funding & Sponsors
Funding source category [1] 301775 0
University
Name [1] 301775 0
Universiti Sultan Zainal Abidin Special Research Grant Scheme 2017 (UniSZA/2017/SRGS/16)
Country [1] 301775 0
Malaysia
Funding source category [2] 301796 0
University
Name [2] 301796 0
Universiti Sains Malaysia
Country [2] 301796 0
Malaysia
Primary sponsor type
University
Name
Institute of Postgraduate Studies, Universiti Sains Malaysia
Address
Institute of Postgraduate Studies, Universiti Sains Malaysia
Health Campus, 16150 Kubang Kerian, Malaysia
Country
Malaysia
Secondary sponsor category [1] 301520 0
University
Name [1] 301520 0
School of Medical Sciences, Universiti Sains Malaysia
Address [1] 301520 0
School of Medical Sciences, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian, Kelantan Malaysia
Country [1] 301520 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302493 0
Human Research Ethics Committee of Universiti Sains Malaysia
Ethics committee address [1] 302493 0
Ethics committee country [1] 302493 0
Malaysia
Date submitted for ethics approval [1] 302493 0
20/02/2017
Approval date [1] 302493 0
22/05/2017
Ethics approval number [1] 302493 0
USM/JEPeM/17020146

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90410 0
Dr Mohammed Dauda Goni
Address 90410 0
Department of Microbiology and Parasitology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.
Country 90410 0
Malaysia
Phone 90410 0
+60102982754
Fax 90410 0
Email 90410 0
dmgoni@yahoo.com
Contact person for public queries
Name 90411 0
Nyi Nyi Naing
Address 90411 0
Institute for Community (Health) Development (i-CODE), Universiti Sultan Zainal Abidin, Gong Badak Campus, 21300 Kuala Nerus, Terengganu, Malaysia
Country 90411 0
Malaysia
Phone 90411 0
+60179381610
Fax 90411 0
Email 90411 0
syedhatim@unisza.edu.my
Contact person for scientific queries
Name 90412 0
Nyi Nyi Naing
Address 90412 0
Institute for Community (Health) Development (i-CODE), Universiti Sultan Zainal Abidin, Gong Badak Campus, 21300 Kuala Nerus, Terengganu, Malaysia
Country 90412 0
Malaysia
Phone 90412 0
+60179381610
Fax 90412 0
Email 90412 0
syedhatim@unisza.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data from this study will be anonymous and not be disclosed


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1204Ethical approval    376838-(Uploaded-08-02-2019-02-43-20)-Study-related document.pdf



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.