Travel HealthTOURIST2NCT03262337
TOURIST 2: Tracking Of Urgent Risks In Swiss Travelers
An observational study of Travel Health and Mobile Health Technology (mHealth), run by University of Zurich at 2 sites in Switzerland.
Trial summary
New mobile Health (mHealth) technology creates an opportunity to approach travel medicine research in a different way, revolutionising our understanding of risks to travellers. Using mHealth technology, the Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), developed a TRAVEL app… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Travel Health, Mobile Health Technology (mHealth), Elderly Travelers
- What is being tested?
- none, this is an observational study
- How many people
- 793 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 Sep 2017to 31 Mar 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Study recruitment will be conducted at the University of Zurich Travel Clinic and the Travel Clinic at the Swiss Tropical and Public Health Institute. That means that individuals seeking pre-travel advice at one of the two Travel Clinics will be asked to participate based inclusion criteria defined above. Furthermore, patients with chronic diseases will be referred to the Travel Clinics by various specialized clinics at the University Hospitals of Zurich and Basel (Gastroenterology, Rheumatology, Pneumology, Cardiology)
Who may be able to join
- Informed Consent
- Traveler to Thailand, China, India, Brazil, Peru or Tanzania
- German-speaking (level 3 or higher)
- Literate (able to read and write in German - level 3 or higher)
- Capable of operating Smartphone application for data collection
- Traveling to Thailand, China, India, Brazil, Peru or Tanzania for ≤ 4 weeks
Who cannot join
- not fulfilling inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Andreas Neumayr
Basel, Canton of Basel-City, 4051
University of Zurich, Epidemiology, Biostatistics and Prevention Institute, Travel Clinic
Zurich, 8001
About this study
Official title: An Observational Study Using a Smartphone-app Supported Electronic Survey and Localization Tracking to Map Risk Behaviors and Symptoms of Swiss Travelers to Thailand, China, India, Brazil, Peru and Tanzania From 2 Swiss Travel Clinics
New mobile Health (mHealth) technology creates an opportunity to approach travel medicine research in a different way, revolutionising our understanding of risks to travellers. Using mHealth technology, the Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), developed a TRAVEL app in collaboration with the Eidgnössische Technische Hochschule (ETH) Zurich.
By using this new technology, an extensive collection of data (prospective collection of individual travel behaviour and experienced health events, mapping the travel itinerary via global positioning system (GPS), linking to publicly available local weather data and data on disease endemicity) can be combined and an unprecedented abundance of information on travel behaviour and experienced risks can be obtained. These data will allow a much better understanding of travel risk profiles using cluster analysis. By simultaneously recording health outcomes, the relationship between travel risk profiles and health events can be assessed. In this study, the investigators will address several major shortcomings in travel health in tropical and subtropical destinations by improving the understanding of poorly assessed and potentially underestimated health threats (e.g. risk of accidents and injury, mental health disorders), and travel risks specific to elderly travellers and travellers with chronic conditions. These findings will directly feed back into individual travel advice given by practitioners in Switzerland and finally world-wide.
Read the detailed description
New mobile Health (mHealth) technology creates an opportunity to approach travel medicine research in a different way, revolutionising our understanding of risks to travellers. Using mHealth technology, the Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), developed a TRAVEL app in collaboration with the Eidgnössische Technische Hochschule (ETH) Zurich.
By using this new technology, an extensive collection of data (prospective collection of individual travel behaviour and experienced health events, mapping the travel itinerary via global positioning system (GPS), linking to publicly available local weather data and data on disease endemicity) can be combined and an unprecedented abundance of information on travel behaviour and experienced risks can be obtained. These data will allow a much better understanding of travel risk profiles using cluster analysis. By simultaneously recording health outcomes, the relationship between travel risk profiles and health events can be assessed. In this study, the investigators will address several major shortcomings in travel health in tropical and subtropical destinations by improving the understanding of poorly assessed and potentially underestimated health threats (e.g. risk of accidents and injury, mental health disorders), and travel risks specific to elderly travellers and travellers with chronic conditions.
1000 clients traveling to Thailand, China, India, Brazil, Peru or Tanzania will be recruited from the Travel Clinics in Zurich and Basel and through advertising at local travel agents and the universities of ETH and UZH from September 2017 until February 2019. After completing an intake at the clinic, participants will be given the option to use their own Smartphone for data collection, or to use a phone owned by the UZH-EBPI during travel. Participants will use a data collection app for questionnaire responses during and after travel including: a daily questionnaire on travel behaviors, daily symptoms questionnaire, and localization tracking, showing the participants' travel path and locations.
- Conditions
- Travel Health, Mobile Health Technology (mHealth), Elderly Travelers, Chronic Diseased Travelers, Risk Behavior
- Being tested
- none, this is an observational study
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none, this is an observational studyOther
none, this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Elderly Travelers | approximately 135 travelers with an age >= 60 years will be enrolled Receives: Other: none, this is an observational study | |
| Chronic diseased travelers | approximately 225 travelers with a chronic disease will be enrolled Receives: Other: none, this is an observational study | |
| Healthy travelers | approximately 640 healthy travelers with be enrolled Receives: Other: none, this is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported risk behaviors
The study participant will report on daily risk behaviors prior to, during and after travel in a daily app-based questionnaire
Measured: for a maximum of 4 weeks during travel
Secondary outcomes (1)
Self-reported symptoms
The study participant will report on experienced symptoms/health events prior to, during and after travel in a daily app-based questionnaire
Measured: for a maximum of 4 weeks during travel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start18 Sep 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Travel HealthStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute
- Responsible party
- Sponsor
- Investigators
- Silja Bühler, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262337
- Sponsor's protocol ID
- PB_2017_00412
- Acronym
- TOURIST2
- Status last verified
- Oct 2017
- First submitted
- 16 Aug 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farnham A, Blanke U, Stone E, Puhan MA, Hatz C. Travel medicine and mHealth technology: a study using smartphones to collect health data during travel. J Travel Med. 2016 Sep 4;23(6):taw056. doi: 10.1093/jtm/taw056. Print 2016 Jun.
PubMed 27592821
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Using a Smartphone-app Supported Electronic Survey and Localization Tracking to Map Risk Behaviors and Symptoms of Swiss Travelers to Thailand, China, India, Brazil, Peru and Tanzania From 2 Swiss Travel Clinics
- ClinicalTrials.gov ID
- NCT03262337
- Acronym / sponsor ID
- TOURIST2 / PB_2017_00412
- Conditions
- Travel Health, Mobile Health Technology (mHealth), Elderly Travelers, Chronic Diseased Travelers, Risk Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 25 Aug 2017 (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.
New mobile Health (mHealth) technology creates an opportunity to approach travel medicine research in a different way, revolutionising our understanding of risks to travellers. Using mHealth technology, the Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), developed a TRAVEL app in collaboration with the Eidgnössische Technische Hochschule (ETH) Zurich.
By using this new technology, an extensive collection of data (prospective collection of individual travel behaviour and experienced health events, mapping the travel itinerary via global positioning system (GPS), linking to publicly available local weather data and data on disease endemicity) can be combined and an unprecedented abundance of information on travel behaviour and experienced risks can be obtained. These data will allow a much better understanding of travel risk profiles using cluster analysis. By simultaneously recording health outcomes, the relationship between travel risk profiles and health events can be assessed. In this study, the investigators will address several major shortcomings in travel health in tropical and subtropical destinations by improving the understanding of poorly assessed and potentially underestimated health threats (e.g. risk of accidents and injury, mental health disorders), and travel risks specific to elderly travellers and travellers with chronic conditions. These findings will directly feed back into individual travel advice given by practitioners in Switzerland and finally world-wide.
Detailed description
New mobile Health (mHealth) technology creates an opportunity to approach travel medicine research in a different way, revolutionising our understanding of risks to travellers. Using mHealth technology, the Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), developed a TRAVEL app in collaboration with the Eidgnössische Technische Hochschule (ETH) Zurich.
By using this new technology, an extensive collection of data (prospective collection of individual travel behaviour and experienced health events, mapping the travel itinerary via global positioning system (GPS), linking to publicly available local weather data and data on disease endemicity) can be combined and an unprecedented abundance of information on travel behaviour and experienced risks can be obtained. These data will allow a much better understanding of travel risk profiles using cluster analysis. By simultaneously recording health outcomes, the relationship between travel risk profiles and health events can be assessed. In this study, the investigators will address several major shortcomings in travel health in tropical and subtropical destinations by improving the understanding of poorly assessed and potentially underestimated health threats (e.g. risk of accidents and injury, mental health disorders), and travel risks specific to elderly travellers and travellers with chronic conditions.
1000 clients traveling to Thailand, China, India, Brazil, Peru or Tanzania will be recruited from the Travel Clinics in Zurich and Basel and through advertising at local travel agents and the universities of ETH and UZH from September 2017 until February 2019. After completing an intake at the clinic, participants will be given the option to use their own Smartphone for data collection, or to use a phone owned by the UZH-EBPI during travel. Participants will use a data collection app for questionnaire responses during and after travel including: a daily questionnaire on travel behaviors, daily symptoms questionnaire, and localization tracking, showing the participants' travel path and locations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elderly Travelers | – | Other: none, this is an observational studyapproximately 135 travelers with an age >= 60 years will be enrolled |
| Chronic diseased travelers | – | Other: none, this is an observational studyapproximately 225 travelers with a chronic disease will be enrolled |
| Healthy travelers | – | Other: none, this is an observational studyapproximately 640 healthy travelers with be enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study recruitment will be conducted at the University of Zurich Travel Clinic and the Travel Clinic at the Swiss Tropical and Public Health Institute. That means that individuals seeking pre-travel advice at one of the two Travel Clinics will be asked to participate based inclusion criteria defined above. Furthermore, patients with chronic diseases will be referred to the Travel Clinics by various specialized clinics at the University Hospitals of Zurich and Basel (Gastroenterology, Rheumatology, Pneumology, Cardiology)
Key inclusion criteria (6 listed)
- Informed Consent
- Traveler to Thailand, China, India, Brazil, Peru or Tanzania
- German-speaking (level 3 or higher)
- Literate (able to read and write in German - level 3 or higher)
- Capable of operating Smartphone application for data collection
Key exclusion criteria (1 listed)
- not fulfilling inclusion criteria
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 |
|---|---|---|
| none, this is an observational studynone, this is an observational study | Other | Chronic diseased travelers, Elderly Travelers, Healthy travelers |
Primary outcome
Self-reported risk behaviors
Time frame: for a maximum of 4 weeks during travel
The study participant will report on daily risk behaviors prior to, during and after travel in a daily app-based questionnaire
1 secondary outcome
Self-reported symptoms
Time frame: for a maximum of 4 weeks during travel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 27592821Farnham A, Blanke U, Stone E, Puhan MA, Hatz C. Travel medicine and mHealth technology: a study using smartphones to collect health data during travel. J Travel Med. 2016 Sep 4;23(6):taw056. doi: 10.1093/jtm/taw056. Print 2016 Jun.
- 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.
Silja Bühler, Dr. principal investigator
University of Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Travel Health and Mobile Health Technology (mHealth), run by University of Zurich at 2 sites in Switzerland.
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 1 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: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported risk behaviors (time frame: for a maximum of 4 weeks during travel). 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 NCT03262337, which also lists 1 linked publication.
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 29 Apr 2021.