Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT03415932
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2018-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Group Intervention Among Refugees in Sweden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'baseline and follow up in one population'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health care consumption', 'timeFrame': 'three months before and after intervention', 'description': 'number of Health care contacts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migration Stress']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Refugees seeking primary care consultation or rehabilitation unit aged 18-65 years were candidates for inclusion. Based on the health care provider's assessment, patients whose health symptoms could be connected to or increased by the migration process were eligible for inclusion -\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT03415932', 'briefTitle': 'Health Group Intervention Among Refugees in Sweden', 'organization': {'class': 'OTHER', 'fullName': 'Region Östergötland'}, 'officialTitle': 'Health Group Intervention Among Refugees in Sweden', 'orgStudyIdInfo': {'id': '20117278-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health education', 'description': 'Assessment of healt care Contacts Before and after intervention', 'interventionNames': ['Behavioral: health education']}], 'interventions': [{'name': 'health education', 'type': 'BEHAVIORAL', 'description': 'Health information by a multimodal team', 'armGroupLabels': ['Health education']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Östergötland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Pia Yngman-Uhlin', 'investigatorAffiliation': 'Region Östergötland'}}}}