Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT03729050
Status:
UNKNOWN
Last Update Posted:
2020-06-30
First Post:
2018-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Coordinators in Specialist Psychiatry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to work (RTW)/entry into work or studies', 'timeFrame': '1 year', 'description': 'Number of Participants that have RTW/entry into work or studies'}, {'measure': 'Magnitude of sick leave', 'timeFrame': '1 year', 'description': 'Proportion of sick leave in the study population'}, {'measure': 'Length of sick leave', 'timeFrame': '1 year', 'description': 'Sick leave duration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mental Disorder', 'Rehabilitation'], 'conditions': ['Mental Disorder', 'Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '32075611', 'type': 'DERIVED', 'citation': 'Andersen A, Berglund E, Anderzen I. Rehabilitation coordinator intervention versus control in psychiatric specialist care for return to work and reduced sick leave: study protocol of a randomised controlled trial. BMC Public Health. 2020 Feb 19;20(1):250. doi: 10.1186/s12889-020-8238-3.'}]}, 'descriptionModule': {'briefSummary': 'REKO-A is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are on sick leave due to mental illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be on sick leave\n* Have moderate to severe affective and / or moderate / severe anxiety disorder, such as: Bipolar disorder, depression, posttraumatic stress disorder, generalized anxiety disorder, neuropsychiatric disability\n* Enrolled at the Academic hospital in Uppsala\n\nExclusion Criteria:\n\n* High suicidal risk\n* Extensive somatic disorders (somatic multichannel)\n* Patients outside Uppsala County\n* Taking part in an ongoing vocational rehabilitation'}, 'identificationModule': {'nctId': 'NCT03729050', 'briefTitle': 'Rehabilitation Coordinators in Specialist Psychiatry', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Rehabilitation Coordinators in Specialist Psychiatry', 'orgStudyIdInfo': {'id': 'REKO-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention with rehabilitation coordinator', 'interventionNames': ['Behavioral: Rehabilitation Coordinator in Specialist Psychiatry']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Rehabilitation Coordinator in Specialist Psychiatry', 'type': 'BEHAVIORAL', 'description': 'Rehabilitation Coordinator service in Specialist Psychiatry', 'armGroupLabels': ['Intervention with rehabilitation coordinator']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-75122', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Åsa Andersén, PHD', 'role': 'CONTACT', 'email': 'asa.andersen@pubcare.uu.se', 'phone': '00184716575'}, {'name': 'Ingrid Anderzén, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uppsala university', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Ingrid Anderzen', 'investigatorAffiliation': 'Uppsala University'}}}}