Condition category
Not Applicable
Date applied
02/11/2020
Date assigned
05/11/2020
Last edited
04/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.ebpi.uzh.ch

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

Publication citations

Additional files

Editorial Notes

02/11/2020: Trial’s existence confirmed by the University of Zurich.