Migration StressNCT03415932
Health Group Intervention Among Refugees in Sweden
A study testing health education in people with Migration Stress, run by Region Östergötland.
Trial summary
This prospective intervention study evaluates whether health education and basic body awareness training reduces health care consumption and improves movement quality among refugees in Sweden. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migration Stress
- What is being tested?
- health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
This prospective intervention study evaluates whether health education and basic body awareness training reduces health care consumption and improves movement quality among refugees in Sweden.
Read the detailed description
Migration is well known to be stressful and to have a negative impact on Health. Multidisciplinary health-promoting group interventions have significantly improved self-rated health. Further, symptom improvement was shown after implementation of physical activity in form of basic body awareness training. In this study a multimodal team consisted of a physiotherapist, nurse, psychologist, dietician, and physician held sessions of three hours weekly for a period of nine weeks. The sessions started with basic body awareness training, followed by theme discussions on symptoms and health strategies. A total of 54 participants completed the intervention. Health care consumption and movement quality were measured before and after the intervention.
- Conditions
- Migration Stress
- Being tested
- health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationBehavioural
Health information by a multimodal team
| Study group | Role | What they receive |
|---|---|---|
| Health education | Experimental | Assessment of healt care Contacts Before and after intervention Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care consumption
number of Health care contacts
Measured: three months before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Jan 2014
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migration StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- baseline and follow up in one population
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Yngman-Uhlin, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415932
- Sponsor's protocol ID
- 20117278-31
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2018
- Last updated
- 1 Feb 2018
- 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 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Group Intervention Among Refugees in Sweden
- ClinicalTrials.gov ID
- NCT03415932
- Acronym / sponsor ID
- 20117278-31
- Conditions
- Migration Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 30 Jan 2018 (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 prospective intervention study evaluates whether health education and basic body awareness training reduces health care consumption and improves movement quality among refugees in Sweden.
Detailed description
Migration is well known to be stressful and to have a negative impact on Health. Multidisciplinary health-promoting group interventions have significantly improved self-rated health. Further, symptom improvement was shown after implementation of physical activity in form of basic body awareness training. In this study a multimodal team consisted of a physiotherapist, nurse, psychologist, dietician, and physician held sessions of three hours weekly for a period of nine weeks. The sessions started with basic body awareness training, followed by theme discussions on symptoms and health strategies. A total of 54 participants completed the intervention. Health care consumption and movement quality were measured before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- baseline and follow up in one population
| Arm | Type | Receives |
|---|---|---|
| Health education | Experimental | Behavioral: health educationAssessment of healt care Contacts Before and after intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| health educationHealth information by a multimodal team | Behavioural | Health education |
Primary outcome
Health care consumption
Time frame: three months before and after intervention
number of Health care contacts
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 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Migration Stress
Recruiting
The Impact of Playing Tetris on Migrants' Mental Health
Post-traumatic Stress Disorder (PTSD), Anxiety Symptoms
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.
Questions about this trial
What is this clinical trial studying?
A study testing health education in people with Migration Stress, run by Region Östergötland.
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 0 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 1 Feb 2018. 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?
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?
Health care consumption (time frame: three months before and after intervention). 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 Feb 2018.