Global Health of Asylum Seekers in FrancePREMENTADANCT05423782
Prevalence of Mental Disorder and Somatic Co-morbidities Among Asylum Seekers in Marseille
An observational study of Global Health of Asylum Seekers in France, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Global Health of Asylum Seekers in France
- How many people
- 419 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2021to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: asylum Seekers in France
Who may be able to join
- 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 )
Who cannot join
- Existence of cognitive disorders (dementia, mental retardation) or language difficulties (dysphasia, aphasia) limiting understanding and expression.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Refugee Health Screener (RHS-15)
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
Measured: 30 minutes
Secondary outcomes (1)
Cumulative Illness Rating Scale (CIRS)
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start11 Feb 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Global Health of Asylum Seekers in FranceStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423782
- Sponsor's protocol ID
- RCAPHM20_0196
- Acronym
- PREMENTADA
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khouani J, Jeannu E, Borlot J, Tinland A, Thery D, Jego M, Gentile G, Auquier P, Tabele C. Care pathway of asylum seekers in the health care access points following inclusion in the PREMENTADA project: an observational study. Public Health. 2024 Jul;232:138-145. doi: 10.1016/j.puhe.2024.04.023. Epub 2024 May 22.
PubMed 38776589
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Mental Disorder and Somatic Co-morbidities Among Asylum Seekers in Marseille
- ClinicalTrials.gov ID
- NCT05423782
- Acronym / sponsor ID
- PREMENTADA / RCAPHM20_0196
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- asylum Seekers in France
Key inclusion criteria (4 listed)
- 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 )
Key exclusion criteria (1 listed)
- Existence of cognitive disorders (dementia, mental retardation) or language difficulties (dysphasia, aphasia) limiting understanding and expression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Cumulative Illness Rating Scale (CIRS)
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 38776589Khouani J, Jeannu E, Borlot J, Tinland A, Thery D, Jego M, Gentile G, Auquier P, Tabele C. Care pathway of asylum seekers in the health care access points following inclusion in the PREMENTADA project: an observational study. Public Health. 2024 Jul;232:138-145. doi: 10.1016/j.puhe.2024.04.023. Epub 2024 May 22.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Global Health of Asylum Seekers in France, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refugee Health Screener (RHS-15) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05423782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.