Condition category
Not Applicable
Date applied
09/05/2016
Date assigned
11/05/2016
Last edited
11/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the summer of 2015, the exodus of Syrian war refugees and saturation of refugee camps in neighbouring countries led to the influx of many asylum-seekers in some European countries, including Belgium. In the existing medical scientific literature little is known and described on health problems of asylum-seekers in Europe. Scientific research needs to document this complex humanitarian emergency, in order to determine the needs of this new population in Europe. The aim of this study is to describe the health complaints and diagnoses made by physicians in asylum seekers arriving in September 2015 in Belgium, in a refugee camp in Brussels after a long and hazardous journey, in order to estimate the (medical) needs of this new population arriving in a Western European country. Once we know exactly what kind of diseases and injury the asylum-seekers suffer from, recommendations can be made to health policy makers and medical teams in order to improve the medical care they will deliver to these patients on a short and on a long term basis.

Who can participate?
Asylum-seekers from the Middle-East and elsewhere arriving in a refugee camp in Brussels between September 5th and October 5th, 2015 and presenting themselves as patients to a Field Hospital organised by Doctors of the World

What does the study involve?
Information on all the participants is collected, including age, gender, country of origin, date of arrival in Belgium, whether the participant has requested or received an appointment with the Belguim Immigration Office, whether they are registered as a asylum-seeker, the location of their shelter, all their physical and mental complaints, their main complaint and any pre-existing medical issues. A main diagnosis in recorded for each participant. Trained physicians then classify these diagnoses into categories. Possible referral for treatment is also recorded

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Level I Medical Field Hospital of Doctors of the World, Refugee Camp (City Center)

When is the study starting and how long is it expected to run for?
September 2015 to October 2015

Who is funding the study?
Research Group on Emergency and Disaster Medicine, of the Free University (Vrije Universiteit) Brussels

Who is the main contact?
Dr Gerlant van Berlaer
gerlant.vanberlaer@uzbrussel.be

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gerlant van Berlaer

ORCID ID

http://orcid.org/0000-0003-3674-9083

Contact details

Laarbeeklaan 101
Brussels
1090
Belgium
+3224763100
gerlant.vanberlaer@uzbrussel.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol (5) Brussels MdM study

Study information

Scientific title

A refugee camp in the center of Europe: observational descriptive sample analysis of demographic and clinical characteristics of asylum seekers arriving in a refugee camp and presenting as patients to a field hospital in Brussels in September 2015

Acronym

Study hypothesis

Hypothesis is that among people in a huddled refugee camp – even in a well-developed country with all medical facilities – respiratory, digestive and other medical problems typical of refugee camps will emerge soon.

Ethics approval

Commission of Medical Ethics (O.G. 016), University Hospital Brussels (Universitair Ziekenhuis Brussel), Brussels, Belgium, 09/12/2015, ref: 143201526433

Study design

Cross sectional observational sample single center study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Community

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Demographic (age, origin, gender, arrival time) and clinical characteristics (complaints, diagnoses, comorbidities, acute treatments and referrals) of asylum-seekers arriving in a refugee camp in Brussels.

Intervention

A prospectively designed template was used to register data for all patients (randomly self-presenting to a Field Hospital in the refugee camp): age, gender, country of origin, date of arrival in Belgium, whether and when patients had requested or received an appointment at the Belgian Immigration Office, or were already officially registered as asylum-seeker, location of shelter, all physical and mental complaints, the chief complaint, and all pre-existing comorbidities.

One primary diagnosis per patient was recorded according to a list of 50 possible diagnoses, adapted from case descriptions in the WHO "Communicable disease control in emergencies" field manual, the Sphere Project Handbook, and a template used in previous humanitarian operations. Post-hoc, trained physicians classified these diagnoses into categories, adapted from ICD-10. All patients with clinical signs of local or generalised infection were classified as a subgroup of "infectious diseases". Finally, possible referral was recorded.

Intervention type

Phase

Drug names

Primary outcome measures

Proportion of diagnosis categories found among asylum seekers in Brussels. The primary diagnoses was made by a physician, based on anamnesis, physical examination, and available point-of-care tests (glucose, pregnancy, …). This was done on the spot during the consultation: after anamnesis, and before eventual referral of the patient.

Secondary outcome measures

A prospectively designed template was used to register data for all patients:
1. Age: the exact age of all patients was asked. Descriptive statistics for this quantitative variable was presented as measure of central tendency and dispersion (median, range, interquartile range IQR). The analyses was broken down for age categories (<5, 5-14, and >15years old).
2. Gender: male or female
3. Country of origin: each patient was asked which country they originally inhabited. These were categorised into regions (Middle East, rest of Asia, Africa, Europe, other).
4. Date of arrival in Belgium: each patient was asked exactly when (date) they arrived in Belgium
5. Appointment at Belgian Immigration Office (BIO): each patient was asked whether and when they had requested or received an appointment at BIO or were already officially registered as asylum-seeker. This was expressed in “days’.
6. Location of shelter: each patient was asked where they resided at the time of the consultation, these were categorised as ‘refugee camp Brussels’, ‘other refugee camps’, Governmental asylum-seeker centers, open air, relatives and friends, foster families, other and unknown.
7. All physical and mental complaints, and which was the “chief complaint” of each patient were recorded by physicians.
8. All pre-existing comorbidities, classified using the case descriptions in the WHO "Communicable disease control in emergencies" field manual.
9. One primary diagnosis per patient was recorded according to a list of 50 possible diagnoses, adapted from case descriptions in the WHO "Communicable disease control in emergencies" field manual, the Sphere Project Handbook, and a template used in previous humanitarian operations. Post-hoc, trained physicians classified these diagnoses into categories, adapted from ICD-10.
10. All patients with clinical signs of local or generalised infection were classified as a subgroup of "infectious diseases".
11. Possible referral was recorded.
Multiple logistic regression analysis was performed to identify factors associated with the asylum-seekers’ health problems, by using 'infection' as an outcome variable, by using origin (other versus Syria, Iraq, Morocco and Afghanistan), age category (0-15, >15 years old) and gender as predictors. Analyses were carried out by using IBM® SPSS® v23.0. All tests were performed using an α-level of 0.05.

Overall trial start date

05/09/2015

Overall trial end date

05/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asylum-seekers (all ages, both genders) from the Middle-East and elsewhere arriving in a refugee camp in Brussels between September 5th and October 5th, 2015
2. Self-presenting as patients to a Field Hospital organised by Doctors of the World

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

4037

Participant exclusion criteria

Patients with missing date of presentation, chief complaint, or single primary diagnosis, and patients not giving oral informed consent were excluded.

Recruitment start date

05/09/2015

Recruitment end date

05/10/2015

Locations

Countries of recruitment

Belgium

Trial participating centre

Level I Medical Field Hospital of Doctors of the World
Refugee Camp (City Center)
Brussels
1000
Belgium

Sponsor information

Organisation

Research Group on Emergency and Disaster Medicine, Free University (Vrije Universiteit) Brussels

Sponsor details

Laarbeeklaan 101 (tav. Spoedgevallendienst)
Brussels
1090
Belgium

Sponsor type

Research organisation

Website

Funders

Funder type

University/education

Funder name

Research Group on Emergency and Disaster Medicine, of the Free University (Vrije Universiteit) Brussels

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We would like to publish the results of our study (as soon as they are available) to all scientists and health care providers in the field, in order to share our findings, and in the hope to be of use to improve the medical care for asylum-seekers arriving in any country in Europe.

Intention to publish date

01/05/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes