ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Respiratory tract infection

Condition category

Condition code

Public Health

Health promotion/education

Infection

Other infectious diseases

Respiratory

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]

Prevention

Intervention code [2]

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]

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]

Single time assessment From day 1 to day 7 after return from Hajj

Primary outcome [2]

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]

single time within 7 days after return from Hajj

Primary outcome [3]

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]

Single time within 7 days after return from Hajj

Secondary outcome [1]

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]

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]

Malaysia

State/province [1]

Kelantan

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universiti Sultan Zainal Abidin Special Research Grant Scheme 2017 (UniSZA/2017/SRGS/16)

Address [1]

Universiti Sultan Zainal Abidin, Gong Badak Campus, 21300 Kuala Nerus, Terengganu, Malaysia.

Country [1]

Malaysia

Funding source category [2]

University

Name [2]

Universiti Sains Malaysia

Address [2]

School of Medical Sciences, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian, Kelantan Malaysia

Country [2]

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]

University

Name [1]

School of Medical Sciences, Universiti Sains Malaysia

Address [1]

School of Medical Sciences, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian, Kelantan Malaysia

Country [1]

Malaysia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee of Universiti Sains Malaysia

Ethics committee address [1]

Setiausaha Jawatankuasa Etika Penyelidikan (Manusia) USM
Bahagian Penyelidikan dan Inovasi (P&I)
USM Kampus Kesihatan.

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

20/02/2017

Approval date [1]

22/05/2017

Ethics approval number [1]

USM/JEPeM/17020146

Summary

Brief summary

This study will be a quasi-experimental study to test the effectiveness of health education module in preventing respiratory viral infection including influenza among Malaysian Hajj pilgrims
The study will compare the ‘Hajj health education module"  versus Normal Hajj smartphone application among pilgrims during the Hajj orientation Participants would be grouped into intervention and control group based on various Hajj companies.

For the intervention Hajj-Health education module application will be provided to each pilgrims and used continuously during the Hajj period. Knowledge, attitude and practice questionnaire before departure and after return from Hajj. Nasopharyngeal will be taken from pilgrims after return from Hajj.

Data available from questionnaires  and laboratory tests will be analyzed to examine whether the health education module has a significant difference in reducing the frequency of laboratory-confirmed respiratory virus infection and improving the knowledge, attitude and practice among the pilgrims

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mohammed Dauda Goni

Address

Department of Microbiology and Parasitology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.

Country

Malaysia

Phone

+60102982754

Fax

[email protected]

Contact person for public queries

Name

Nyi Nyi Naing

Address

Institute for Community (Health) Development (i-CODE), Universiti Sultan Zainal Abidin, Gong Badak Campus, 21300 Kuala Nerus, Terengganu, Malaysia

Country

Malaysia

Phone

+60179381610

Fax

[email protected]

Contact person for scientific queries

Name

Nyi Nyi Naing

Address

Institute for Community (Health) Development (i-CODE), Universiti Sultan Zainal Abidin, Gong Badak Campus, 21300 Kuala Nerus, Terengganu, Malaysia

Country

Malaysia

Phone

+60179381610

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
1204	Ethical 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.

Trial Review

Documents added manually

Documents added automatically