Care System for Newly Arrived MigrantsCoPAMViLNCT04989426
Generalist Cohort of Migrant Patients Consultants in City Medicine
An observational study of Care System for Newly Arrived Migrants, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
This innovative cross-sectional study, carried out in the city, will provide valuable prospective data that will make it possible to identify public health avenues for specific and adapted care both in the medical and social field of newcomers to our territory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Care System for Newly Arrived Migrants
- What is being tested?
- the state of health of newly arrived migrant patients in the year following their arrival in France
- How many people
- 197 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Nov 2021to 25 Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: specific population of major newcomer migrants
Who may be able to join
- Adults (age ≥ 18 years)
- Newly arrived migrants (foreigners born outside France, first arrival in France AND presence in the territory ≤ 1 year)
- 1st medical contact in town medicine in France
Who cannot join
- Refusal of participation
- Communication impossible due to the language barrier despite translation or interpreting (telephone or face-to-face)
Trial locations and contacts
2 sites in 1 country.
France2 sites
CMS Aubervilliers
Aubervilliers, 93000
CMS Saint-Denis
Saint-Denis, 93200
About this study
Official title: State of Health and Integration Into the Health Care System of Migrant Patients, New Arrivals, Consultants in Urban Primary Care Structures,in Seine Saint Denis and in the North of Paris.
This innovative cross-sectional study, carried out in the city, will provide valuable prospective data that will make it possible to identify public health avenues for specific and adapted care both in the medical and social field of newcomers to our territory. Our study will characterize the impact of reforms of the conditions of access to State medical aid and universal health protection on access to care and the state of health of this population. . It will make it possible to participate in the advocacy in favor of access to healthcare for all and the city PASS, the only device allowing access to healthcare in the city for all newcomers regardless of their status.
Read the detailed description
Participants will be informed orally and via an information note written by the doctor during their first medical contact in France or during a follow-up visit within the municipal health center.
The health data comes from the participant's care file and some social data is extracted from the social information system, already existing and used by the reception agents responsible for the consultations. access to rights.
Inclusion visit :
This visit will take place during the first medical visit of eligible patients.
During this visit, the investigative team:
- Checks the inclusion and non-inclusion criteria;
- Gives clear oral and written information;
- Collect the patient's non-opposition;
- Performs the medico-social consultation in accordance with the management recommendations.
Follow-up visits Follow-up will be continued 12 months after the inclusion visit. The rhythm, as well as the nature of the follow-up visits for the patients included, will be defined by the information obtained during the inclusion visit, and will be determined by the doctor in charge of the patient.
For patients included retrospectively The inclusion visit will take place during a follow-up medico-social visit planned as part of the care in one of the participating the municipal health center.
During this visit, the investigative team:
- Checks the inclusion and non-inclusion criteria;
- Gives clear oral and written information;
- Collect the patient's non-opposition;
- Performs the medico-social consultation in accordance with the management recommendations
During the inclusion visit and medical follow-up visits, within the Municipal Health Centers, a consultation on access to rights will also be carried out in order to help patients put together their social file.
- Conditions
- Care System for Newly Arrived Migrants
- Being tested
- the state of health of newly arrived migrant patients in the year following their arrival in France
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the state of health of newly arrived migrant patients in the year following their arrival in FranceOther
the state of health of newly arrived migrant patients in the year following their arrival in France
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of medical and social consultations one year after inclusion.
describe the state of health of newly arrived migrant patients in the year following their arrival in France
Measured: one year after arrival in France
Number of newcomer biological assessments prescribed by the doctor one year after inclusion
describe the state of health of newly arrived migrant patients in the year following their arrival in France
Measured: one year after arrival in France
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start25 Nov 2021
- Primary completion25 Nov 2022
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care System for Newly Arrived MigrantsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989426
- Sponsor's protocol ID
- APHP210936
- Acronym
- CoPAMViL
- Status last verified
- Jun 2024
- First submitted
- 19 Jul 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: * The data will be entered in an electronic CRF: Cleanweb®, hosted in France on a health data host. * Allocation of an individual code to each participant eligible for the research: center number, serial number in the research, initial Last name and initial First name * Use of a correspondence table (kept in the center by the principal investigator until the publication of the research article) Non-identifying data will be entered into an electronic Cleanweb CRF and each participant will be assigned an individual code. The computer session and access to the e-CRF will be protected by a user code and a password.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State of Health and Integration Into the Health Care System of Migrant Patients, New Arrivals, Consultants in Urban Primary Care Structures,in Seine Saint Denis and in the North of Paris.
- ClinicalTrials.gov ID
- NCT04989426
- Acronym / sponsor ID
- CoPAMViL / APHP210936
- Conditions
- Care System for Newly Arrived Migrants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 4 Aug 2021 (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.
This innovative cross-sectional study, carried out in the city, will provide valuable prospective data that will make it possible to identify public health avenues for specific and adapted care both in the medical and social field of newcomers to our territory. Our study will characterize the impact of reforms of the conditions of access to State medical aid and universal health protection on access to care and the state of health of this population. . It will make it possible to participate in the advocacy in favor of access to healthcare for all and the city PASS, the only device allowing access to healthcare in the city for all newcomers regardless of their status.
Detailed description
Participants will be informed orally and via an information note written by the doctor during their first medical contact in France or during a follow-up visit within the municipal health center.
The health data comes from the participant's care file and some social data is extracted from the social information system, already existing and used by the reception agents responsible for the consultations. access to rights.
Inclusion visit :
This visit will take place during the first medical visit of eligible patients.
During this visit, the investigative team:
- Checks the inclusion and non-inclusion criteria;
- Gives clear oral and written information;
- Collect the patient's non-opposition;
- Performs the medico-social consultation in accordance with the management recommendations.
Follow-up visits Follow-up will be continued 12 months after the inclusion visit. The rhythm, as well as the nature of the follow-up visits for the patients included, will be defined by the information obtained during the inclusion visit, and will be determined by the doctor in charge of the patient.
For patients included retrospectively The inclusion visit will take place during a follow-up medico-social visit planned as part of the care in one of the participating the municipal health center.
During this visit, the investigative team:
- Checks the inclusion and non-inclusion criteria;
- Gives clear oral and written information;
- Collect the patient's non-opposition;
- Performs the medico-social consultation in accordance with the management recommendations
During the inclusion visit and medical follow-up visits, within the Municipal Health Centers, a consultation on access to rights will also be carried out in order to help patients put together their social file.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- specific population of major newcomer migrants
Key inclusion criteria (3 listed)
- Adults (age ≥ 18 years)
- Newly arrived migrants (foreigners born outside France, first arrival in France AND presence in the territory ≤ 1 year)
- 1st medical contact in town medicine in France
Key exclusion criteria (2 listed)
- Refusal of participation
- Communication impossible due to the language barrier despite translation or interpreting (telephone or face-to-face)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the state of health of newly arrived migrant patients in the year following their arrival in Francethe state of health of newly arrived migrant patients in the year following their arrival in France | Other | – |
Primary outcome
The number of medical and social consultations one year after inclusion.
Time frame: one year after arrival in France
describe the state of health of newly arrived migrant patients in the year following their arrival in France
Number of newcomer biological assessments prescribed by the doctor one year after inclusion
Time frame: one year after arrival in France
describe the state of health of newly arrived migrant patients in the year following their arrival in France
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 1 Jul 2024.
- Individual participant dataSharing planned: No. * The data will be entered in an electronic CRF: Cleanweb®, hosted in France on a health data host. * Allocation of an individual code to each participant eligible for the research: center number, serial number in the research, initial Last name and initial First name * Use of a correspondence table (kept in the center by the principal investigator until the publication of the research article) Non-identifying data will be entered into an electronic Cleanweb CRF and each participant will be assigned an individual code. The computer session and access to the e-CRF will be protected by a user code and a password.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Care System for Newly Arrived Migrants, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 3 inclusion and 2 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The number of medical and social consultations one year after inclusion. (time frame: one year after arrival in France). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.