- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04961983
A Comprehensive Travel Health Education for Tour Guides in Bali, Indonesia
A Comprehensive Travel Health Education Improving Attitude, Subjective Norm, Perceived Behavioral Control, Role Identity, Actual Behavioral Control, and Intention to Provide Travel Health Information of Tour Guides in Bali
This is a field trial with a randomized pre-test post-test control group design. This trial is the second phase of an exploratory mixed methods research. Prior to this trial, a qualitative study through in-depth interviews to tour guides from 11 language divisions and also policy makers of Indonesian Tour Guide Association Bali branch (HPI Bali). The education model for tour guides were developed based on the integration of theory of planned behavior (TPB) and identity theory. This educational model is expected to improve the behavior of tour guides in providing travel health information to tourists they serve, which is currently still lacking. However, due to the COVID-19 pandemic, the measurement of behavior can not be conducted. Therefore, this trial aims to test the efficacy of the comprehensive education model to improve the indirect and direct determinants of the behavior namely attitude, subjective norms, perceived behavioral control, role identity, actual behavioral control and behavioral intention.
The research hypothesis are:
- The comprehensive travel health education model improves the attitude of tour guides towards providing travel health information to tourists?
- The comprehensive travel health education model improves the subjective norms of tour guides towards providing travel health information to tourists?
- The comprehensive travel health education model improves the perceived behavioral control of tour guides in providing travel health information to tourists?
- The comprehensive travel health education model improves the role identity of tour guides as a travel health promoter for tourists?
- The comprehensive travel health education model improves the actual behavioral control of tour guides in providing travel health information to tourists?
- The comprehensive travel health education model improves the intention of tour guides to provide travel health information to tourists?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Study design: This is a field trial with a randomized pre-test post-test control group design. This trial is the second phase of an exploratory mixed methods research.
- Study setting: Data collection will be conducted in Bali, Indonesia, started from September 2021 to February 2022.
- Study population: The target population in this study are all general tour guides in Bali, Indonesia. The accessible population are general tour guides who are registered as members of HPI Bali who can be reached during the data collection period.
Sample size: The calculation of the minimum sample size in this study was carried out with the assistance of the WHO Sample Size Determination software using the hypothesis test formula for the mean difference of two populations (one-sided).
Based on the sample size calculation with the above formula, the minimum sample size for each group is 69 tour guides. Taking into account the drop-out rate of 10%, the number of samples for each group is 76 tour guides. Thus, the total number of samples for intervention and comparison groups in this study is 152 tour guides.
- Sample selection: The sample selection was carried out with disproportionate stratified random sampling using a sampling frame namely the list of tour guides who are registered as the members of Indonesian Guides Association (HPI) Bali Branch from 11 language divisions. The number of samples in each division for intervention and control group ranged from 5 to 8 subjects.
- Sample allocation: Permuted block randomization.
Study variables:
- Dependent variable is comprehensive travel health education model.
Intermediate variables are:
- attitude towards providing travel health information to tourists,
- subjective norms towards providing travel health information to tourists,
- perceived behavioral control of providing travel health information to tourists,
- role identity,
- actual behavioral control.
- Dependent variable is intention to provide travel health information to tourists.
- Controll variables are:
Controlled by design:
- history of formal health education,
- ownership of a smartphone or laptop with WhatsApp and Zoom application,
- familiarity with Zoom usage,
- familiarity with WhatsApp usage.
Controlled by analysis:
- age,
- sex,
- education,
- length of work,
- employment status,
- tourists' country of origin,
- type of tourism activities,
- employer's policy.
- Research instrument:
The instrument that will be used in this study is a questionnaire. The measurement using questionnaire will be conducted before the intervention (pre-test) and after the intervention (post-test). The developed questionnaire consists of several parts, namely the identity or socio-demographic characteristics of the subjects, job characteristics, characteristics of tourists served, attitudes, subjective norms, perceived behavioral control, role identity, actual behavior control and behavioral intentions.
The questionnaire was developed based on the guidelines for developing a questionnaire for TPB-based interventions and the results of the qualitative study. The assessment for each statement item on the attitude, subjective norm, perceived behavioral control and role identity, uses a Likert scale consisting of seven scales, namely: 1 = strongly disagree, 2 = disagree; 3 = disagree, 4 = undecided, 5 = somewhat agree, 6 = agree; 7 = strongly agree.
The questionnaire on the actual behavior control section consists of questions related to knowledge about prevention and first aid for tourism health problems. Questions to measure knowledge were developed based on the material provided during the intervention. The correct answer for each knowledge question will get a score 1, while the wrong or 'do not know' answer will be given a score 0.
The questionnaire on the behavioral intention section is also written in statement format. The assessment for each statement item uses a Likert scale consisting of seven scales, namely: a scale of 1 = strongly not intending, 2 = not intending; 3 = lack of intention, 4 = undecided, 5 = somewhat intend, 6 = intend; 7 = very intent.
The validity and reliability of the questionnaire will be tested before it being used in data collection. Twenty tour guides will be involved in the pilot test of the questionnaire. If necessary, improvements will be made to the questionnaire based on the test results. The questionnaire is self-administered and will be given to the subjects in digital format.
9. Data analysis:
- Descriptive statistic Quantitative data obtained from the questionnaire will be analyzed descriptively by calculating the frequency distribution for data on a categorical scale and by calculating the total value, mean, median, standard deviation and range of values from minimum to maximum on continuous scale data. On the variables of attitude, subjective norm, perceived behavioral control, and role identity, a positive statement will get a score of 1 = strongly disagree; 1 = strongly disagree; 2 = disagree; 3 = disagree; 4 = doubtful; 5 = somewhat agree; 6 = agree; 7 = strongly agree. As for negative statements, the score given is the opposite, namely a score of 7 = strongly disagree; 6 = disagree; 5 = disagree; 4 = doubtful; 3 = somewhat agree; 2 = agree; 1 = strongly agree. The actual behavioral control score was 1 for correct answer and 0 for wrong answer and 'do not know' answer.
- Chi square test Comparison of sample characteristics in the intervention and control groups in terms of control variables (age, gender, education, length of work, employment status, tourists' country of origin, type of tourism activities and employer's policy) was also carried out using the chi square test. Through this test, it will be known whether there are differences in the two groups based on these variables. If the p value > 0.05, the two groups are the same (comparable), whereas if p value ≤ 0.05 then the two groups are different in terms of the variables tested. Variables that have a p value ≤ 0.05 will be tested in multivariate analysis.
- Normality test Data normality test is conducted to determine whether or not the data on attitude, subjective norms, perceived behavioral control, actual behavior control, role identity and behavioral intentions scores are normally distributed, as a prerequisite for being able to perform parametric statistical tests. Based on the sample size, the normality test will be carried out using the Kolmogorov-Smirnov test. If the normality test produces a p value > 0.05 then the data distribution is normally distributed. On the other hand, the data is not normally distributed if the p ≤ 0.05.
- Homogeneity test The purpose of the homogeneity test is to find out whether the two groups to be compared have the same variance. According to the sample size, homogeneity test will be carried out using Levene's test. If the results of the homogeneity test show a p value > 0.05 then the variance between groups is homogeneous. On the other hand, if the p value ≤ 0,05, the variance of the two groups is not homogeneous.
Mean comparison test The mean comparison test will be conducted to determine whether there is a difference in the mean between the intervention and the control group (difference in the mean of two independent samples). The mean comparison procedure used in this study is the independent samples t test. However, testing with independent samples t test is a parametric test which assumes the data is normally distributed and both groups have the same variance. The interpretation of the test results is that Ho is accepted if the p value > 0.05 or the zero value lies within the confidence interval for the difference in the mean, on the other hand Ho is rejected if the p value ≤ 0,05 or the zero value lies outside the confidence interval for the mean difference of the two groups. If the data is not normally distributed, the data will be transformed. Furthermore, if the transformation cannot make the data normally distributed, the data will be analyzed by non-parametric statistical tests, namely the Mann Whitney U test.
In addition to the comparison of the mean between the intervention and comparison groups, a comparison test of the means was also carried out for the control variables. For categorical-scale control variables with two categories, a t-test was performed, such as a comparative analysis of the mean for the intervention and control groups. Meanwhile, for control variables that have more than two categories, an analysis of variance (ANOVA) test will be carried out. If the assumptions for the parametric statistical test are not met, the Kruskal-Wallis test is performed.
- Multivariate analysis After the bivariate analysis, a multivariate analysis was carried out which aims to control the inter-correlation between the variables under study. In multivariate analysis, all dependent variables are tested simultaneously. If the assumptions for parametric statistical analysis are met, the statistical test used is multivariate analysis of variance (MANOVA). MANOVA is chosen because there is more than one continuous-scale dependent variable to be tested and more than one categorical-scale independent variable with two or more categories. If the assumptions are not met, then a non-parametric MANOVA statistical test is performed.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ni Made Sri Nopiyani, MD, MPH
- Phone Number: +6281236327788
- Email: sri.nopiyani@unud.ac.id
Study Contact Backup
- Name: I Md Ady Wirawan, MD, MPH, Ph.D
- Phone Number: +6281239394465
- Email: ady.wirawan@unud.ac.id
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Active members of HPI Bali,
- Age less than 55 years old,
- Have worked as a tour guide for one year or more,
- Have a smart phone or laptop that equipped with Zoom and WhatsApp application,
- Familiar with Zoom meeting,
- Using WhatsApp actively.
Exclusion Criteria:
- Holding a structural position at HPI Bali,
- Unwilling to work as a tour guide after the re-opening of tourism,
- Have a formal health education background,
- Unwilling to participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Tour guides who will receive a comprehensive travel health education model.
|
The comprehensive travel health education model consists of:
|
No Intervention: Control group
Tour guides who will receive no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean score of attitude
Time Frame: 3 months
|
Attitude is a psychological tendency expressed by tour guides towards the behavior of providing travel health information to tourists.
Attitude will be measured through a self-administered questionnaire developed based on the TPB questionnaire development guideline.
The data measurement scale is ordinal which is expressed on a Likert scale (1 = strongly disagree, 2 = disagree; 3 = disagree, 4 = neutral, 5 = somewhat agree, 6 = agree; 7 = strongly agree).
Data will be analysed in interval scale.
|
3 months
|
Mean score of subjective norm
Time Frame: 3 months
|
Subjective norm is the perception of tour guides on the extent to which the behavior of providing health information to tourists is a behavior that is expected by the tourists, by their employers, HPI, and the community.
Subjective norms will be measured through a self-administered questionnaire which was developed based on TPB questionnaire development guideline.
The measurement scale is ordinal which is expressed on a Likert scale (1 = strongly disagree, 2 = disagree; 3 = disagree, 4 = neutral, 5 = somewhat agree, 6 = agree; 7 = strongly agree).
Data will be analysed in interval scale.
|
3 months
|
Mean score of perceived behavioral control
Time Frame: 3 months
|
Perceived behavioral control is the confidence of tour guides in their ability to carry out the behavior of providing information to tourists regarding prevention and first aid of health problems.
Perceived behavioral control will be measured through a self-administered questionnaire which was developed based on the TPB questionnaire development guideline.
The measurement scale is ordinal which is expressed on a Likert scale (1 = strongly disagree, 2 = disagree; 3 = disagree, 4 = neutral, 5 = somewhat agree, 6 = agree; 7 = strongly agree).
Data will be analysed in interval scale.
|
3 months
|
Mean score of actual behavioral control
Time Frame: 3 months
|
Actual behavioral control is tour guide's knowledge about the prevention of travel health problems and first aid to tourists who experience health problems.
Actual behavioral control will be measured through a self-administered questionnaire.
The measurement scale is ordinal which is expressed on a Likert scale (1 = strongly disagree, 2 = disagree; 3 = disagree, 4 = neutral, 5 = somewhat agree, 6 = agree; 7 = strongly agree).
Data will be analysed in interval scale.
Knowledge measurement scale is interval.
The correct answer for each knowledge question will get a score = 1, while the question with the wrong answer or do not know gets a score = 0. Data will be analysed in interval scale.
|
3 months
|
Mean score of role identity
Time Frame: 3 months
|
Role identity is tour guide's perception of the extent to which the provision of information related to the prevention and first aid of tourism health problems to tourists is a part of the tour guide's role.
Role identity will be measured through a self-administered questionnaire.The measurement scale is ordinal which is expressed on a Likert scale (1 = strongly disagree, 2 = disagree; 3 = disagree, 4 = neutral, 5 = somewhat agree, 6 = agree; 7 = strongly agree).
Data will be analysed in interval scale.
|
3 months
|
Mean score of behavioral intention
Time Frame: 3 months
|
Behavioral intention is the willingness of tour guides to convey information related to the prevention and first aid of travel health problems to the tourists they serve.
Intention will be measured through a self-administered questionnaire which was developed based on the TPB questionnaire development guideline.
The data measurement scale is ordinal which is expressed on a Likert scale (1 = strongly disinterested, 2 = not intending; 3 = lack of intention, 4 = neutral, 5 = somewhat intend, 6 = intend; 7 = very intend).
Data will be analysed in interval scale.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ni Made Sri Nopiyani, MD, MPH, Udayana University
Publications and helpful links
General Publications
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- Wirawan IMA, Putri WCWS, Kurniasari NMD, Mulyawan KH, Hendrayana MA, Suharlim C. Geo-mapping of hazards, risks, and travel health services in Bali: Results from the first stage of the integrated travel health surveillance and information system at destination (TravHeSID) project. Travel Med Infect Dis. 2020 Sep-Oct;37:101698. doi: 10.1016/j.tmaid.2020.101698. Epub 2020 Apr 28.
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- Nopiyani NMS, Januraga PP, Wirawan IMA, Bakta IM. Comprehensive Travel Health Education for Tour Guides: Protocol for an Exploratory Sequential Mixed Methods Research. JMIR Res Protoc. 2022 May 23;11(5):e33840. doi: 10.2196/33840.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021.03.1.0515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Research on Healthcare Performance Lab U1290RecruitingSedentary Behavior | Sedentary Time | Health Behavior | Health-Related Behavior | Physical InactivityFrance
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World Health OrganizationLondon School of Hygiene and Tropical Medicine; University of Ghana; Biomedical... and other collaboratorsRecruitingHealth-Related Behavior | Adolescent Behavior | Adolescent Development | Health Care Seeking BehaviorGhana, Tanzania, Zimbabwe
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Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Attitude | Health Behavior | Health KnowledgeTurkey
Clinical Trials on Comprehensive Travel Health Education Model
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Fu Jen Catholic UniversityNot yet recruiting
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Gazi UniversityCompleted
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Marmara UniversityNot yet recruitingBreast Cancer Awareness and BSE in Visually Impaired WomenTurkey
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Baqiyatallah Medical Sciences UniversityCompletedOral HealthIran, Islamic Republic of
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Saglik Bilimleri UniversitesiNot yet recruitingPregnant Women | Gestational Diabetes
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Hacettepe UniversityCompletedType 2 DiabetesTurkey
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Ondokuz Mayıs UniversityCompletedDiabetes Mellitus | Family MembersTurkey
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Istanbul University - Cerrahpasa (IUC)CompletedBreastfeeding EducationTurkey