Behavior, HealthNCT04961983
A Comprehensive Travel Health Education for Tour Guides in Bali, Indonesia
A study testing Comprehensive Travel Health Education Model in people with Behavior, Health and Travel-Related Illness, run by Udayana University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Health, Travel-Related Illness
- What is being tested?
- Comprehensive Travel Health Education Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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?
Read the 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.
- 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.
- Conditions
- Behavior, Health, Travel-Related Illness
- Being tested
- Comprehensive Travel Health Education Model
- Keywords
- travel health, health promotion, tour guides
- Medical subject headings
- Health Behavior, Travel-Related Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Travel Health Education ModelBehavioural
The comprehensive travel health education model consists of:
- Online training: 10 hours (2 days) online education via Zoom. The topics that will be delivered during the training includes:
- The potential roles of tour guides in tourists' health,
- The importance of travel health information for tourists,
- Assessment of tourist's health risks,
- Prevention and first aid of various travel health problems Topics related to tour guides will be delivered by the tourism experts, while topics related to travel health will be provided by travel medicine experts, Faculty of Medicine, Udayana University. Participants will also receive a travel health guide book.
- Weekly travel health Information sharing through WhatsApp group for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Tour guides who will receive a comprehensive travel health education model. Receives: Behavioral: Comprehensive Travel Health Education Model |
| Control group | No intervention | Tour guides who will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score of attitude
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.
Measured: 3 months
Mean score of subjective norm
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.
Measured: 3 months
Mean score of perceived behavioral control
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.
Measured: 3 months
Mean score of actual behavioral control
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.
Measured: 3 months
Mean score of role identity
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.
Measured: 3 months
Mean score of behavioral intention
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Behavior, HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to two groups (intervention and control groups) in parallel for the duration of the study. The allocation of participants into the intervention and control groups will be carried out using permuted block randomization technique.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ni Made Sri Nopiyani, Udayana University
- Investigators
- Ni Made Sri Nopiyani, MD, MPH, Principal investigator, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961983
- Sponsor's protocol ID
- 2021.03.1.0515
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.
PubMed 21929476Ajzen I. The theory of planned behaviour is alive and well, and not ready to retire: a commentary on Sniehotta, Presseau, and Araujo-Soares. Health Psychol Rev. 2015;9(2):131-7. doi: 10.1080/17437199.2014.883474. Epub 2014 Feb 12. No abstract available.
PubMed 26209198Alqahtani AS, Tashani M, Heywood AE, Booy R, Rashid H, Wiley KE. Exploring Australian Hajj Tour Operators' Knowledge and Practices Regarding Pilgrims' Health Risks: A Qualitative Study. JMIR Public Health Surveill. 2019 May 23;5(2):e10960. doi: 10.2196/10960.
PubMed 31124464Johansson Arhem KM, Gysin N, Nielsen HV, Surya A, Hellgren U. Low and Declining Risk for Malaria in Visitors to Indonesia: A Review of Local Indonesian and European Travelers' Data and a Suggestion for New Prophylactic Guidelines. J Travel Med. 2015 Nov-Dec;22(6):389-95. doi: 10.1111/jtm.12233. Epub 2015 Oct 13.
PubMed 26464104Armitage CJ, Conner M. Efficacy of the Theory of Planned Behaviour: a meta-analytic review. Br J Soc Psychol. 2001 Dec;40(Pt 4):471-99. doi: 10.1348/014466601164939.
PubMed 11795063Avcikurt C, Koroglu O, Koroglu A, Avcikurt AS. HIV/AIDS awareness and attitudes of tour guides in Turkey. Cult Health Sex. 2011 Feb;13(2):233-43. doi: 10.1080/13691058.2010.522733.
PubMed 21058083Bauer I. The health impact of tourism on local and indigenous populations in resource-poor countries. Travel Med Infect Dis. 2008 Sep;6(5):276-91. doi: 10.1016/j.tmaid.2008.05.005. Epub 2008 Aug 9.
PubMed 18760250Bertman V, Petracca F, Makunike-Chikwinya B, Jonga A, Dupwa B, Jenami N, Nartker A, Wall L, Reason L, Kundhlande P, Downer A. Health worker text messaging for blended learning, peer support, and mentoring in pediatric and adolescent HIV/AIDS care: a case study in Zimbabwe. Hum Resour Health. 2019 Jun 7;17(1):41. doi: 10.1186/s12960-019-0364-6.
PubMed 31174543Broglio K. Randomization in Clinical Trials: Permuted Blocks and Stratification. JAMA. 2018 Jun 5;319(21):2223-2224. doi: 10.1001/jama.2018.6360. No abstract available.
PubMed 29872845Cooke R, Dahdah M, Norman P, French DP. How well does the theory of planned behaviour predict alcohol consumption? A systematic review and meta-analysis. Health Psychol Rev. 2016 Jun;10(2):148-67. doi: 10.1080/17437199.2014.947547. Epub 2014 Sep 17.
PubMed 25089611Dunleavy G, Nikolaou CK, Nifakos S, Atun R, Law GCY, Tudor Car L. Mobile Digital Education for Health Professions: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. J Med Internet Res. 2019 Feb 12;21(2):e12937. doi: 10.2196/12937.
PubMed 30747711Gautret P, Angelo KM, Asgeirsson H, Lalloo DG, Shaw M, Schwartz E, Libman M, Kain KC, Piyaphanee W, Murphy H, Leder K, Vincelette J, Jensenius M, Waggoner J, Leung D, Borwein S, Blumberg L, Schlagenhauf P, Barnett ED, Hamer DH; GeoSentinel Global Surveillance Network. Rabies post-exposure prophylaxis started during or after travel: A GeoSentinel analysis. PLoS Negl Trop Dis. 2018 Nov 13;12(11):e0006951. doi: 10.1371/journal.pntd.0006951. eCollection 2018 Nov.
PubMed 30422981Giovanetti F. Methanol poisoning among travellers to Indonesia. Travel Med Infect Dis. 2013 May-Jun;11(3):190-3. doi: 10.1016/j.tmaid.2013.03.013. Epub 2013 Apr 6.
PubMed 23566856Grech V, Grech P, Fabri S. A risk balancing act - Tourism competition using health leverage in the COVID-19 era. Int J Risk Saf Med. 2020;31(3):121-130. doi: 10.3233/JRS-200042.
PubMed 32597822Hirata K, Ogawa T, Fujikura H, Ogawa Y, Hirai N, Nakagawa-Onishi T, Uno K, Takeyama M, Kasahara K, Nakamura-Uchiyama F, Konishi M, Mikasa K. Characteristics of health problems in returned overseas travelers at a tertiary teaching hospital in a suburban area in Japan. J Infect Chemother. 2018 Aug;24(8):682-685. doi: 10.1016/j.jiac.2018.02.003. Epub 2018 Mar 2.
PubMed 29503227
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04961983
- Acronym / sponsor ID
- 2021.03.1.0515
- Conditions
- Behavior, Health, Travel-Related Illness
- Keywords
- travel health, health promotion, tour guides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to two groups (intervention and control groups) in parallel for the duration of the study. The allocation of participants into the intervention and control groups will be carried out using permuted block randomization technique.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Comprehensive Travel Health Education ModelTour guides who will receive a comprehensive travel health education model. |
| Control group | No intervention | –Tour guides who will receive no intervention. |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Travel Health Education ModelThe comprehensive travel health education model consists of: 1. Online training: 10 hours (2 days) online education via Zoom. The topics that will be delivered during the training includes: * The potential roles of tour guides in tourists' health, * The importance of travel health information for tourists, * Assessment of tourist's health risks, * Prevention and first aid of various travel health problems Topics related to tour guides will be delivered by the tourism experts, while topics related to travel health will be provided by travel medicine experts, Faculty of Medicine, Udayana University. Participants will also receive a travel health guide book. 2. Weekly travel health Information sharing through WhatsApp group for 2 months. | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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- Background: PubMed 26209198Ajzen I. The theory of planned behaviour is alive and well, and not ready to retire: a commentary on Sniehotta, Presseau, and Araujo-Soares. Health Psychol Rev. 2015;9(2):131-7. doi: 10.1080/17437199.2014.883474. Epub 2014 Feb 12. No abstract available.
- Background: PubMed 31124464Alqahtani AS, Tashani M, Heywood AE, Booy R, Rashid H, Wiley KE. Exploring Australian Hajj Tour Operators' Knowledge and Practices Regarding Pilgrims' Health Risks: A Qualitative Study. JMIR Public Health Surveill. 2019 May 23;5(2):e10960. doi: 10.2196/10960.
- Background: PubMed 26464104Johansson Arhem KM, Gysin N, Nielsen HV, Surya A, Hellgren U. Low and Declining Risk for Malaria in Visitors to Indonesia: A Review of Local Indonesian and European Travelers' Data and a Suggestion for New Prophylactic Guidelines. J Travel Med. 2015 Nov-Dec;22(6):389-95. doi: 10.1111/jtm.12233. Epub 2015 Oct 13.
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- Background: PubMed 21058083Avcikurt C, Koroglu O, Koroglu A, Avcikurt AS. HIV/AIDS awareness and attitudes of tour guides in Turkey. Cult Health Sex. 2011 Feb;13(2):233-43. doi: 10.1080/13691058.2010.522733.
- Background: PubMed 18760250Bauer I. The health impact of tourism on local and indigenous populations in resource-poor countries. Travel Med Infect Dis. 2008 Sep;6(5):276-91. doi: 10.1016/j.tmaid.2008.05.005. Epub 2008 Aug 9.
- Background: PubMed 31174543Bertman V, Petracca F, Makunike-Chikwinya B, Jonga A, Dupwa B, Jenami N, Nartker A, Wall L, Reason L, Kundhlande P, Downer A. Health worker text messaging for blended learning, peer support, and mentoring in pediatric and adolescent HIV/AIDS care: a case study in Zimbabwe. Hum Resour Health. 2019 Jun 7;17(1):41. doi: 10.1186/s12960-019-0364-6.
- Background: PubMed 29872845Broglio K. Randomization in Clinical Trials: Permuted Blocks and Stratification. JAMA. 2018 Jun 5;319(21):2223-2224. doi: 10.1001/jama.2018.6360. No abstract available.
- Background: PubMed 25089611Cooke R, Dahdah M, Norman P, French DP. How well does the theory of planned behaviour predict alcohol consumption? A systematic review and meta-analysis. Health Psychol Rev. 2016 Jun;10(2):148-67. doi: 10.1080/17437199.2014.947547. Epub 2014 Sep 17.
- Background: PubMed 30747711Dunleavy G, Nikolaou CK, Nifakos S, Atun R, Law GCY, Tudor Car L. Mobile Digital Education for Health Professions: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. J Med Internet Res. 2019 Feb 12;21(2):e12937. doi: 10.2196/12937.
- Background: PubMed 30422981Gautret P, Angelo KM, Asgeirsson H, Lalloo DG, Shaw M, Schwartz E, Libman M, Kain KC, Piyaphanee W, Murphy H, Leder K, Vincelette J, Jensenius M, Waggoner J, Leung D, Borwein S, Blumberg L, Schlagenhauf P, Barnett ED, Hamer DH; GeoSentinel Global Surveillance Network. Rabies post-exposure prophylaxis started during or after travel: A GeoSentinel analysis. PLoS Negl Trop Dis. 2018 Nov 13;12(11):e0006951. doi: 10.1371/journal.pntd.0006951. eCollection 2018 Nov.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ni Made Sri Nopiyani, MD, MPH principal investigator
Udayana University
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Travel Health Education Model in people with Behavior, Health and Travel-Related Illness, run by Udayana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ni Made Sri Nopiyani, MD, MPH (+6281236327788, sri.nopiyani@unud.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score of attitude (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961983, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.