Plain English Summary
Background and study aims
This project aims to develop and verify a travel medical questionnaire designed to assess the risk of falling ill while travelling abroad. Travellers are exposed to an increased risk of developing medical conditions linked to various risk factors such as their travel destination, travel duration, travel purpose and their health condition. The Ready-To-Go questionnaire, which was developed in collaboration with a travel medical expert group, assesses all the aforementioned risk factors. The questionnaire is intended to be filled out by travellers as medical preparation before their departure. Four risk categories result from the questionnaire according to travellers' risk of falling ill during their journey. The risk category emerging from the questionnaire will help travellers and medical professionals to decide if a pre-travel health consultation at a specialized Travel Clinic is necessary. Furthermore, the Ready-To-Go questionnaire can serve as a link between travel medical health care and primary health care.
To verify the accuracy of this questionnaire, customers scheduled for a pre-travel health consultation at the Travel Clinic of the University of Zurich will be asked to complete the questionnaire.
The aims of this study are to develop a medical pre-travel triage questionnaire to objectify travellers’ health risk, to assess the questionnaire's feasibility in a travel medical setting, and to validate the Ready-To-Go questionnaire risk categories by comparing their correlation to the risk assessment by pre-travel health consultants, to the destination-specific indication of anti-malaria medication, and of yellow fever vaccination respectively.
Who can participate?
Adults over the age of 18 years who attend the Travel Clinic of the University of Zurich for a pre-travel health consultation. Furthermore, participants must be fluent in either English or German.
What does the study involve?
Participants in the Ready-To-Go project will be asked to fill out the Ready-To-Go questionnaire to the best of their knowledge before their pre-travel health consultation at the Travel Clinic of the University of Zurich. There are no other requirements.
What are the possible benefits and risks of participating?
There will be no immediate benefit to those taking part in the Ready-To-Go project. However, the participation in this project could result in the widespread use of the Ready-To-Go questionnaire and therefore benefit future travellers. Participants are not exposed to any health risks by participating in this project.
Where is the study run from?
The Epidemiology, Biostatistics and Prevention Institute of the University of Zurich (Switzerland). The recruitment of study participants takes place at the affiliated Travel Clinic.
When is the study starting and how long is it expected to run for?
From January 2020 to January 2021
Who is funding the study?
The University of Zurich (Switzerland)
Who is the main contact?
1. Med. pract. Anna Gazzotti
anna.gazzotti@uzh.ch
2. Dr. med. Sabine Haller
sabine.haller@uzh.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sabine Haller
ORCID ID
http://orcid.org/0000-0001-6275-5167
Contact details
Hirschengraben 84
Zurich
8001
Switzerland
No telephone available
sabine.haller@uzh.ch
Type
Public
Additional contact
Ms Anna Gazzotti
ORCID ID
Contact details
Hirschengraben 84
Zurich
8001
Switzerland
No telephone available
anna.gazzotti@uzh.ch
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Development and validation of a medical pre-travel triage questionnaire: Ready-To-Go Questionnaire
Acronym
Ready-To-Go
Study hypothesis
Travelers who are assigned a high-risk category according to the Ready-To-Go questionnaire are more likely to be assessed as high-risk travelers by pre-travel health consultants and are more likely to travel to a destination with an indication for anti-malaria medication or yellow fever vaccination respectively and therefore require a specialised pre-travel health consultation.
Ethics approval
Approved 15/10/2020, Ethics Committee Zurich (Stampfenbachstrasse 12, 8090 Zürich, Switzerland; +41 43 259 79 70; info.kek@kek.zh.ch), ref: 2020-02109
Study design
Single-centre observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Screening
Patient information sheet
See additional file
Condition
Encounter for health counseling related to travel, prevention of medical conditions in travelers
Intervention
Over a period of time of three months, participants will be enrolled in this study will be asked to fill out the Ready-To-Go questionnaire prior to their pre-travel health consultation at the Travel Clinic of the University of Zurich. The Ready-To-Go questionnaire and its scoring algorithm were developed in collaboration with an expert panel comprising two senior travel medical experts and two senior physicians working in Travel Clinics. The questionnaire's items can be broadly divided into questions on travelers' itinerary (travel destination, travel duration, travel purpose) and questions on their health status (pre-existing medical conditions, current medication, allergies, undesirable reactions to vaccinations, pregnancy or breastfeeding).
There are no further requirements to be fulfilled by study participants.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Risk assessment by the pre-travel health consultant using four categories the Ready-To-Go questionnaire at baseline and validated by the assigned consultant after the pre-travel health consultation
2. Destination-specific indication for anti-malaria medication using a yes/no question in the Ready-To-Go questionnaire at baseline and validated by the assigned consultant after the pre-travel health consultation
3. Destination-specific indication for yellow fever vaccination regardless of the participants’ vaccination status using a yes/no question in the Ready-To-Go questionnaire at baseline and validated by the assigned consultant after the pre-travel health consultation
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/01/2020
Overall trial end date
31/01/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Travel clinic customer scheduled for a pre-travel health consultation
2. Age ≥18 years
3. Fluent in either German or English
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. No informed consent provided
Recruitment start date
01/11/2020
Recruitment end date
31/01/2021
Locations
Countries of recruitment
Switzerland
Trial participating centre
Travel Clinic, Epidemiology, Biostatistics and Prevention Institute
University of Zurich
Hirschengraben 84
Zurich
8001
Switzerland
Sponsor information
Organisation
University of Zurich
Sponsor details
Epidemiology
Biostatistics and Prevention Institute
Hirschengraben 84
Zurich
8001
Switzerland
+41 44 63 44679
jan.fehr@uzh.ch
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Universität Zürich
Alternative name(s)
University of Zurich, UZH
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Switzerland
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan
The datasets generated and/or analysed during the current study are/will be available upon request and approval from the Sponsor of this study.
Intention to publish date
01/05/2021
Participant level data
Available on request
Basic results (scientific)
Publication list