Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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11 February 2019 |
Main ID: |
ISRCTN13523620 |
Date of registration:
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11/05/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A refugee camp in the center of Europe: clinical characteristics of asylum seekers in Brussels in September 2015
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Scientific title:
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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 |
Date of first enrolment:
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05/09/2015 |
Target sample size:
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4037 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN13523620 |
Study type:
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Observational |
Study design:
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Cross sectional observational sample single center study (Screening)
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Gerlant
van Berlaer |
Address:
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Laarbeeklaan 101
1090
Brussels
Belgium |
Telephone:
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+3224763100 |
Email:
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gerlant.vanberlaer@uzbrussel.be |
Affiliation:
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Telephone:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Patients with missing date of presentation, chief complaint, or single primary diagnosis, and patients not giving oral informed consent were excluded.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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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. Not Applicable
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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 a-level of 0.05.
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Secondary ID(s)
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Protocol (5) Brussels MdM study
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Source(s) of Monetary Support
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Research Group on Emergency and Disaster Medicine, of the Free University (Vrije Universiteit) Brussels
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Ethics review
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Status:
Approval date:
Contact:
Commission of Medical Ethics (O.G. 016), University Hospital Brussels (Universitair Ziekenhuis Brussel), Brussels, Belgium, 09/12/2015, ref: 143201526433
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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05/10/2015 |
URL:
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