Ready-To-Go Project – Development and verification of a travel medical questionnaire
| ISRCTN | ISRCTN10172086 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10172086 |
- Submission date
- 02/11/2020
- Registration date
- 05/11/2020
- Last edited
- 09/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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 December 2020 (updated 01/06/2021, previously: 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
Contact information
Scientific
Hirschengraben 84
Zurich
8001
Switzerland
 ORCID ID |
0000-0001-6275-5167 |
|---|---|
| Phone | No telephone available |
| sabine.haller@uzh.ch |
Public
Hirschengraben 84
Zurich
8001
Switzerland
| Phone | No telephone available |
|---|---|
| anna.gazzotti@uzh.ch |
Study information
| Study design | Single-centre observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | ISRCTN10172086_PIS_english_v2.2, 03.10.2020.pdf |
| Scientific title | Development and validation of a medical pre-travel triage questionnaire: Ready-To-Go Questionnaire |
| Study acronym | Ready-To-Go |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2020 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Travel clinic customer scheduled for a pre-travel health consultation 2. Age ≥18 years 3. Fluent in either German or English |
| Key exclusion criteria | 1. No informed consent provided |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Hirschengraben 84
Zurich
8001
Switzerland
Sponsor information
University/education
Epidemiology, Biostatistics and Prevention Institute
Hirschengraben 84
Zurich
8001
Switzerland
| Phone | +41 44 63 44679 |
|---|---|
| jan.fehr@uzh.ch | |
| Website | http://www.ebpi.uzh.ch |
"ROR" |
https://ror.org/02crff812 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Zurich, Switzerland, University of Zurich, UZH
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/08/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v2.2 | 03/10/2020 | 02/12/2020 | No | Yes |
| Results article | 05/03/2022 | 09/03/2022 | Yes | No |
Additional files
- ISRCTN10172086_PIS_english_v2.2, 03.10.2020.pdf
- Uploaded 02/12/2020
Editorial Notes
09/03/2022: Publication reference added.
19/07/2021: The intention to publish date was changed from 01/07/2021 to 01/08/2021.
01/06/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2021 to 31/12/2020.
2. The overall end date was changed from 31/01/2021 to 31/12/2020.
3. The intention to publish date was changed from 01/05/2021 to 01/07/2021.
4. The plain English summary was updated to reflect these changes.
5. The total final enrolment was added
02/12/2020: The participant information sheet has been uploaded as an additional file.
02/11/2020: Trial’s existence confirmed by the University of Zurich.
