- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05423782
Prevalence of Mental Disorder and Somatic Co-morbidities Among Asylum Seekers in Marseille (PREMENTADA)
Introduction : World Health Organization (WHO) considers that the heterogeneity of concepts and definitions of migrants is an obstacle to obtaining evidence to inform public health policies. Thus, it recommends distinguishing refugees from asylum seekers. Asylum seekers are migrants who recently arrived in their host country and whose administrative situation is being examined. They do not have the same access to health care or the same rights as refugees.
In France in 2021, 78,372 major people filled a first asylum application, a 26.4% increase compared to 2020 Regarding the mental health of exiles, a literature review informs us that 31.5% of them suffer from post-traumatic stress disorder (PTSD), 31.5% from depression and 11.1% from anxiety disorders. However, these data are taken from studies that do not make a distinction between refugees and asylum seekers These missing data are a hindrance to the development of efficient strategies for the management of these populations within the health systems of Western countries.
The primary objective of this study was to describe the health status of asylum seekers who have recently arrived in their Western host country. The secondary objective was to investigate potential explanatory factors for the health status of asylum seekers.
Method: Single-center, cross-sectional, observational epidemiological study. The Refugee health screener (RHS15) questionnaire and the Cumulative Illness Rating Scale (CIRS) will be administered by a trained interviewer to each patient included on the day of their inclusion, in the asylum seekers reception platform (PADA).Potential use of tobacco, existence of an adapted treatment in case of a detected pathology and certain socio-demographic data will also be collected.
A telephone interpreting service will be used in the case of an allophone patient whose spoken language is not spoken by the interviewer. Each patient included will have an appointment to perform a standardised blood and urine sample.
Benefits : PREMENTADA study will provide a better understanding of the health status of the population of asylum seekers in France. As the existence of data is a prerequisite for evidence-based medicine, we notice the lack of previous studies specifically addressing this population in France.
Study Overview
Status
Conditions
Detailed Description
Introduction : World Health Organization (WHO) considers that the heterogeneity of concepts and definitions of migrants is an obstacle to obtaining evidence to inform public health policies. Thus, it recommends distinguishing refugees from asylum seekers. Asylum seekers are migrants who recently arrived in their host country and whose administrative situation is being examined. They do not have the same access to health care or the same rights as refugees.
In France in 2021, 78,372 major people filled a first asylum application, a 26.4% increase compared to 2020 Regarding the mental health of exiles, a literature review informs us that 31.5% of them suffer from post-traumatic stress disorder (PTSD), 31.5% from depression and 11.1% from anxiety disorders. However, these data are taken from studies that do not make a distinction between refugees and asylum seekers These missing data are a hindrance to the development of efficient strategies for the management of these populations within the health systems of Western countries.
The primary objective of this study was to describe the health status of asylum seekers who have recently arrived in their Western host country. The secondary objective was to investigate potential explanatory factors for the health status of asylum seekers.
Method: Single-center, cross-sectional, observational epidemiological study. The Refugee health screener (RHS15) questionnaire and the Cumulative Illness Rating Scale (CIRS) will be administered by a trained interviewer to each patient included on the day of their inclusion, in the asylum seekers reception platform (PADA).Potential use of tobacco, existence of an adapted treatment in case of a detected pathology and certain socio-demographic data will also be collected.
A telephone interpreting service will be used in the case of an allophone patient whose spoken language is not spoken by the interviewer. Each patient included will have an appointment to perform a standardised blood and urine sample.
Benefits : PREMENTADA study will provide a better understanding of the health status of the population of asylum seekers in France. As the existence of data is a prerequisite for evidence-based medicine, we notice the lack of previous studies specifically addressing this population in France.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13005
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Coming to asylum seekers reception platform in Marseille
- Have the cognitive capacity to consent to participation in the study
- Holders of a first asylum application receipt (not older than 21 days )
Exclusion Criteria:
- Existence of cognitive disorders (dementia, mental retardation) or language difficulties (dysphasia, aphasia) limiting understanding and expression.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Refugee Health Screener (RHS-15)
Time Frame: 30 minutes
|
The RHS-15 is a valid 15-item instrument screening to detect on asylum seekers and refugees Post traumatic stress disorder (PTSD), anxiety or depression symptoms.
14 items are rated on a 5-point Likert scale (0 = not at all to 4 = extremely).
The last item is assessing the general ability to handle stress on a 5-point Likert scale and a distress thermometer (DT) ranging from 0 to 10.
A screening result is positive if the sum of the first 14 items ≥ 12 or if the DT is ≥ 5
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Illness Rating Scale (CIRS)
Time Frame: 20 minutes
|
The CIRS is a comprehensive measure of multimorbidity previously validated on homeless people.
Each item is assigned a severity score by means of an assessment of the impact on the patient: 1 (no problem), 2 (current mild problem or past significant problem), 3 (moderate disability or morbidity), 4 (severe problem), 5 (extremely severe or life-threatening problem).
The CIRS classifies all items into 14 body systems (including one on mental disorder) to obtain a final cumulative score.
|
20 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCAPHM20_0196
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Global Health of Asylum Seekers in France
-
Rennes University HospitalUnknownAdult Asylum Seekers Who Have Applied for Asylum at the Regional Prefecture in RennesFrance
-
University Hospital, GrenobleCompletedEvaluate the Cost of a PIPAC Procedure and the Associated Hospital Stay in FranceFrance
-
AVEO Pharmaceuticals, Inc.CompletedFood Effect of Tivozanib in Health SubjectsUnited States
-
Hutchison Medipharma LimitedCompletedFood Effect of Fruquintinib in Health SubjectsChina
-
Universidad Francisco MarroquínEcole Polytechnique, France; The SHM Foundation, UKCompletedExclusive Breastfeeding | Co-production of Health in Communities
-
Hasselt UniversityUnknownBeneficial Health Effects of Living in Filtered AirBelgium
-
dfusion IncNational Institute of Environmental Health Sciences (NIEHS)CompletedEffect of Game in Increasing Environmental Health LiteracyUnited States
-
Sakarya UniversityEge UniversityCompletedAssessment of Oral Health Status of Patients in Pediatric Intensive Care UnitsTurkey
-
University of Maryland, College ParkNational Institute on Drug Abuse (NIDA); Medical Research Council, South AfricaCompletedSubstance-Related Disorders | HIV | Substance Use | Substance Use Disorders | Treatment Adherence | Treatment Adherence and Compliance | Stigmatization | Delivery of Health Care | Stigma, Social | Attitude of Health Personnel | Community Health Workers | Health Personnel | Health Personnel Attitude | Health Care Seeking... and other conditionsSouth Africa
-
Research and Publication officeCompletedPerceptions of Health Policy Education | Engagement in Policy RolesSudan