Study design and sampling
A quasi-experimental study design was employed to assess the impact of the smartphone-based health education intervention on the reduction of the incidence of ILI. The incidence, duration of symptoms and the episodes of ILI were assessed using a validated self-administrated questionnaire [18] administered in July 2019 and September 2019 as a preintervention survey and a postintervention survey respectively. Out of the eight Hajj and Umrah companies approached for enrollment in the study, only two companies agreed to participate in the study. Therefore, one company was purposively selected for implementing the intervention and the other one was selected as control group. The Hajj companies selected for intervention and control are located in two separate states of Kelantan and Kuala Lumpur respectively. A sample size of 60 participants per group would achieve a significant difference in studied outcome between intervention and control group using a two-sided test with α = 0.05 and power = 0.8. Participants who met the inclusion and exclusion criteria from the Hajj companies were enrolled for the study (Fig. 1). The intervention phase was guided by the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) statement.
Study participants and location
The study participants are pilgrims who attended the Hajj orientation course organized by private Hajj companies in Kelantan state Malaysia during the recruitment period. Kelantan state is predominantly a Muslims state with about 96.8% of its population being Muslims and belongs to the Malay ethnic group. Pilgrims were selected to participate in the study based on pre-defined inclusion and exclusion criteria. Hajj pilgrims from Malaysia attending the Hajj orientation course, 18 years old and above, ability to read and write and willing participate were included in the study. Exclusion criteria included pilgrims participating in lesser Hajj, health-care workers and those that cannot read and write.
Pilgrims were categorized into ‘at increased risk' as those in which influenza vaccine and pneumococcal vaccine are strongly recommended i.e pilgrims aged 50 years and above and/or had pre-existing health conditions such as asthma, diabetics, lung or kidney diseases based Malaysian Clinical Practical Guidelines (19). Aside these, other pilgrims and those less than the age of 50 years were classified as ‘non-risk pilgrims'. During the enrolment stage, if participants met the selection criteria, informed consent were then taken.
Health education intervention module
The intervention module used in this study is the smartphone application known as the Hajj health educational modules (Hajj-HEM) developed in Malay language [20]. This application was developed to guide Hajj pilgrims from Malaysia towards the prevention of ILI as well as increasing their level of knowledge, attitude and practice towards the prevention of respiratory diseases. The participants were notified that the application is used only for research purpose and is only available to the participants that consented to participate. The Hajj-HEM was developed through a process of consultations with a panel of experts consisting of epidemiologist, microbiologist, health educationist, computer scientist and medical statistician. The module was developed based on the theory of the health belief model (HBM). This theory has a broad spectrum of applicability in intervention studies and a guide in dealing with many health-related issues and adherence to treatment regimens. Applying the model to developing persuasive educational messages for healthy behaviour is widely supported. The module consisted of five main activities applied from the HBM [21] divided into four sections (before Hajj, during Hajj, after Hajj and formative assessment). The HBM was utilized to enhance the pilgrims’ motivation to make lifestyle changes during Hajj.
The Health education intervention application (Hajj HEM) has two major components, including (1) pages for registering the users and collecting the individual’s personal health data, which is the information users wants to protect in the app; (2) pages demonstrating the overview of respiratory tract infection and prevention steps for contracting the infections. First of all, the user registers an account and key in some personal health information. Users can go to the application based on the menu options. Users can also go to the formative assessment section and use the interactive questions and answers to assess their understanding of the health education module. To overcome the challenges of lost in internet connection, the application was designed to function even without internet connection once it is installed in the smartphone.
Module validation and pre-testing
The content validity of the Respiratory tract infection prevention Hajj health education module was assessed in collaboration with experts in respiratory diseases and public health and epidemiology; include researcher’s supervisors and other lecturers in the department of microbiology, community medicine; as well as those in the area of educational studies, for proper scrutiny. Information technology (IT) experts also validated the application. In addition, the educational module was tested among 20 pilgrims who did not participate in the study for clarity of meaning, language and the flow of contents.
Intervention group
The intervention delivery of the health education module was done in with the aid of research assistants. The intervention on respiratory tract infection prevention was delivered to the participants for a period of one to two weeks before departure to Hajj pilgrimage. The delivery of the intervention was through self-download of the newly developed application known as the “Hajj HEM” through the google play store with the help of the research assistant for the study. The delivery of the module was closely monitored and supervised by the researcher, while giving necessary feed-back to the research assistants to ensure that the module was properly downloaded. The privacy of the users were respected in line with Malaysia’s Personal Data Protection Act (PDPA).
Control group
The control group received the normal Hajj guide application (M-Hajj DSS and M-Umrah application) developed by Mohamed et al [22]. Similarly, research assistants were involved in the implementation of intervention in the control group.
Compliance of health education module by participants
Participants were encouraged to be compliant regarding the usage of the smartphone application before, during and after Hajj. The formative assessment section was included in the module for the evaluations of participants comprehension, learning needs and progress throughout the intervention. Formative assessments also help the researcher identify concepts that participants are struggling to understand. how participant and compliance of the app. Similarly, sections were provided regarding “Feedback from users about the content” and “Feedback from users about the app”.
Data collection
Data collection was conducted using a validated self-administrated questionnaire administered in July 2018 and September 2019 as a preintervention survey and a postintervention survey, respectively [23]. The questionnaire consist of four sections named A, B, C and D for socio-demographic variables, knowledge, attitude and practices related to ILI respectively. Section A consists of statements relating to socio-demographic characteristics such as age, gender, race and marital status, occupational status, level of education, previous Hajj or Umrah experience in the last 5 years, vaccinations history, and presence of comorbidities and presence of RTI prior to departure to Hajj. Section B consist of items with ‘Yes’, ’No’ and ‘I don’t know’ options relating to knowledge of ILI. Section C includes questions on attitudes regarding ILI with strongly agree, agree, not sure, disagree and strongly disagree options. Section D consists of items related to practices towards ILI with ‘Always’, 'Occasional' and 'Never' options. Results of the reliability test carried out showed Cronbach’s coefficient alpha for knowledge, attitude and practice was 0.777, 0.709 and 0.729 respectively.
Statistical analyses
The data were examined and cleaned before the final analysis to ensure all values are entered appropriately and within the correct range. The data were all initially entered in SPSS 24.0. data analyses were performed with IBM Statistical Package for Social Sciences (SPSS) version 24. All data checked for missing values. Frequency and percentage were used to summarize categorical variables such as race, occupation, educational qualification, history of previous vaccination, previous Hajj and Umrah experience, presence of comorbidities. Mean and standard deviation was used as the measures of central tendency and dispersion, to summarize continuous variables such as age. Pearson Chi-square test was done to get a baseline comparison of the groups by their socio-demographic characteristics, history of vaccination, presence of respiratory tract infection symptoms before departure and the presence of influenza-like illnesses signs and symptoms. Fisher’s Exact test was conducted for variables which equal or more than 20% of the cells had expected frequency less than five observations. Independent t-test was performed to determine the between-group differences in the total knowledge scores, attitude scores, and practice scores at baseline.