TOURIST 2: Tracking Of Urgent Risks In Swiss Travelers (TOURIST2)

April 27, 2021 updated by: University of Zurich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
793

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8001
        • University of Zurich, Epidemiology, Biostatistics and Prevention Institute, Travel Clinic
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4051
        • Andreas Neumayr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- not fulfilling inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Elderly Travelers
approximately 135 travelers with an age >= 60 years will be enrolled
Other: none, this is an observational study
none, this is an observational study
Chronic diseased travelers
approximately 225 travelers with a chronic disease will be enrolled
Other: none, this is an observational study
none, this is an observational study
Healthy travelers
approximately 640 healthy travelers with be enrolled
Other: none, this is an observational study
none, this is an observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
for a maximum of 4 weeks during travel

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported symptoms
Time Frame: for a maximum of 4 weeks during travel
The study participant will report on experienced symptoms/health events prior to, during and after travel in a daily app-based questionnaire
for a maximum of 4 weeks during travel

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss Tropical & Public Health Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silja Bühler, Dr., University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PB_2017_00412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Risk Behavior

Clinical Trials on none, this is an observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings