Refugee HealthHealthIntroNCT04973215
HealthIntro - Health Perspective in the Introduction Program
An observational study of Refugee Health, run by University of Tromso.
Trial summary
Health problems seem one major reason for why not all refugees, especially women, fulfill the introduction program (IP) and enter the labour market after the end of the program. This challenges integration, and can lead to increased inequalities in society. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Refugee Health
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to May 2025
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Work package 1: all participants in the introduction program, since start of the program in Norway, and their family relations. Work package 2: persons with refugee status settled in Harstad, Senja, or Sør-Varanger municipality who participate in the introduction program during the project period and have a self-reported health problem (sample 1), employees working in Harstad, Senja, or Sør-Varanger municipality with experience with refugees and the introduction program during their work Work package 3: families with refugee status settled in Harstad, Senja, or Sør-Varanger municipality, which have one or several health problems within the family and of which one or both parents participate in the introduction program.
Who may be able to join
- refugee status
- participate or have participated in the introduction program in Norway
- refugee status
- participate in the introduction program in Harstad, Senja, or Sør-Varanger municipality during the project period and since at least one year at enrollment
- have a self-reported health problem
- has professional experience with refugees in Harstad, Senja, or Sør-Varanger municipality
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- currently working in Harstad, Senja, or Sør-Varanger municipality
- above 18 years of age
- refugee status
- living together with family including one or more children
- participate in the introduction program in Harstad, Senja, or Sør-Varanger municipality during the project period and since at least one year at enrollment
- have a self-reported health problem within the family
Who cannot join
- not refugee status
- not participated in the introduction program in Norway
- Work package 2:
- no refugee status
- do not participate in the introduction program
- do not have a health problem
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- under 18 years of age
- not currently working in Harstad, Senja, or Sør-Varanger municipality
- Work package 3:
- no refugee status
- do not participate in the introduction program
- do not live together with family
- do not have a health problem within the family
Trial locations and contacts
No sites are listed yet.
Sindre Myhr contact
About this study
Official title: HealthIntro - a Study to Increase the Successful Participation of Refugees With Health Problems in the Introduction Program
Health problems seem one major reason for why not all refugees, especially women, fulfill the introduction program (IP) and enter the labour market after the end of the program. This challenges integration, and can lead to increased inequalities in society. The HealthIntro pilot-project and existing knowledge point towards a mismatch between the IP's goal to integrate as many refugees as possible into the labour market as soon as possible, and the demanding situation refugees with complex (health) challenges face after resettlement in the host country. Particular barriers seem related to the little flexibility of the introduction law, difficulties with collaboration between public services and with involving refugees in decision-making regarding program adjustments. It is known that refugees have more health problems than the rest of the population. Additionally, current trends in integration policy result in increasing numbers of refugees with complex challenges in municipalities, often families in which one or several members have health problems. It is therefore of high importance to develop strategies that enable municipalities to work more effectively with these most vulnerable group of refugees in the early phase of resettlement and during the IP.
In collaboration with three North Norwegian municipalities and refugees, the investigators will explore how health problems interconnect with program participation on the national level, the municipal level and in a family context. Moreover, the investigators will use this knowledge to collaboratively generate ideas on how to improve the strategic work in municipalities with refugees with health problems. More specifically, the investigators will link registerdata on a national level, conduct explorative qualitative studies addressing the system level in municipalities, and the family and everday life context of refugee families, and conduct an action research inspired study to initiating change in municipalities.
Read the detailed description
This study is funded by The Norwegian Research Council (project number 319050)
- Conditions
- Refugee Health
- Being tested
- no intervention
- Keywords
- immigration, refugees, introduction program, health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this is not an intervention study
| Study group | Role | What they receive |
|---|---|---|
| work package 1 | all participants in Norwegian introduction program and their family relations Receives: Other: no intervention | |
| work package 2 | strategic sample of refugees with health problems currently participating in the introduction program Receives: Other: no intervention | |
| work package 3 | 3-6 families from which one or more participate in the introduction program and one or more have health problems Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work package 1: Number of refugees dropping out of the introduction program or being unemployed after the end of the program; diagnoses associated with drop out of the program .
Work packages 2-4 are qualitative studies and cannot be described in terms of outcome measures due to methodological reasons
Measured: WP 1: 5-10 years after having finished the introduction program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refugee HealthStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- NORCE Norwegian Research Centre AS, FAFO Research foundation, Harstad municipality, Senja municipality, Sør-Varanger municipality
- Responsible party
- Principal investigator, Johanna Laue, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973215
- Sponsor's protocol ID
- 237875
- Acronym
- HealthIntro
- Status last verified
- Jul 2021
- First submitted
- 23 Jun 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthIntro - a Study to Increase the Successful Participation of Refugees With Health Problems in the Introduction Program
- ClinicalTrials.gov ID
- NCT04973215
- Acronym / sponsor ID
- HealthIntro / 237875
- Conditions
- Refugee Health
- Keywords
- immigration, refugees, introduction program, health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- NORCE Norwegian Research Centre AS, FAFO Research foundation, Harstad municipality, Senja municipality, Sør-Varanger municipality
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 22 Jul 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.
Health problems seem one major reason for why not all refugees, especially women, fulfill the introduction program (IP) and enter the labour market after the end of the program. This challenges integration, and can lead to increased inequalities in society. The HealthIntro pilot-project and existing knowledge point towards a mismatch between the IP's goal to integrate as many refugees as possible into the labour market as soon as possible, and the demanding situation refugees with complex (health) challenges face after resettlement in the host country. Particular barriers seem related to the little flexibility of the introduction law, difficulties with collaboration between public services and with involving refugees in decision-making regarding program adjustments. It is known that refugees have more health problems than the rest of the population. Additionally, current trends in integration policy result in increasing numbers of refugees with complex challenges in municipalities, often families in which one or several members have health problems. It is therefore of high importance to develop strategies that enable municipalities to work more effectively with these most vulnerable group of refugees in the early phase of resettlement and during the IP.
In collaboration with three North Norwegian municipalities and refugees, the investigators will explore how health problems interconnect with program participation on the national level, the municipal level and in a family context. Moreover, the investigators will use this knowledge to collaboratively generate ideas on how to improve the strategic work in municipalities with refugees with health problems. More specifically, the investigators will link registerdata on a national level, conduct explorative qualitative studies addressing the system level in municipalities, and the family and everday life context of refugee families, and conduct an action research inspired study to initiating change in municipalities.
Detailed description
This study is funded by The Norwegian Research Council (project number 319050)
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| work package 1 | – | Other: no interventionall participants in Norwegian introduction program and their family relations |
| work package 2 | – | Other: no interventionstrategic sample of refugees with health problems currently participating in the introduction program |
| work package 3 | – | Other: no intervention3-6 families from which one or more participate in the introduction program and one or more have health problems |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Work package 1: all participants in the introduction program, since start of the program in Norway, and their family relations. Work package 2: persons with refugee status settled in Harstad, Senja, or Sør-Varanger municipality who participate in the introduction program during the project period and have a self-reported health problem (sample 1), employees working in Harstad, Senja, or Sør-Varanger municipality with experience with refugees and the introduction program during their work Work package 3: families with refugee status settled in Harstad, Senja, or Sør-Varanger municipality, which have one or several health problems within the family and of which one or both parents participate in the introduction program.
Key inclusion criteria (12 listed)
- refugee status
- participate or have participated in the introduction program in Norway
- refugee status
- participate in the introduction program in Harstad, Senja, or Sør-Varanger municipality during the project period and since at least one year at enrollment
- have a self-reported health problem
Key exclusion criteria (13 listed)
- not refugee status
- not participated in the introduction program in Norway
- no refugee status
- do not participate in the introduction program
- do not have a health problem
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 |
|---|---|---|
| no interventionthis is not an intervention study | Other | work package 1, work package 2, work package 3 |
Primary outcome
Work package 1: Number of refugees dropping out of the introduction program or being unemployed after the end of the program; diagnoses associated with drop out of the program .
Time frame: WP 1: 5-10 years after having finished the introduction program
Work packages 2-4 are qualitative studies and cannot be described in terms of outcome measures due to methodological reasons
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Sindre Myhr contact
Questions about this trial
What is this clinical trial studying?
An observational study of Refugee Health, run by University of Tromso.
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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Laue (004796237993, johanna.laue@uit.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work package 1: Number of refugees dropping out of the introduction program or being unemployed after the end of the program; diagnoses associated with drop out of the program . (time frame: WP 1: 5-10 years after having finished the introduction program). 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 22 Jul 2021.