Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01801969
Status:
UNKNOWN
Last Update Posted:
2016-03-18
First Post:
2013-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Return to Work and QOL Following TBI. Impact of Rehabilitation Service.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 653}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-17', 'studyFirstSubmitDate': '2013-02-06', 'studyFirstSubmitQcDate': '2013-02-27', 'lastUpdatePostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to return to work', 'timeFrame': 'up to 11 years post-injury', 'description': 'Data Source: Register (DREAM)'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '1-10 years post-injury', 'description': 'Data Source: Questionnaire (QUOLIBRI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brain injuries', 'Rehabilitation services', 'Return to Work', 'Quality of life'], 'conditions': ['Brain Injuries', 'Return to Work', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services.\n\nIn Denmark rehabilitation services vary been regions and municipalities. Hospital based rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized by the municipalities\n\nThe first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life.\n\nThe second purpose is to investigate whether municipality size affects quality of life and return to work after severe TBI.\n\nData on return to work are derived from a national register on labor market attachment. Data on quality of life are derived from a questionnaire.\n\nThe study population is identified from the Danish Head Trauma Database. The completeness and accuracy of the database will be investigated as the first part of the project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals suffering from severe TBI (GCS\\<9) from the Danish Head Trauma Database', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-64\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01801969', 'briefTitle': 'Return to Work and QOL Following TBI. Impact of Rehabilitation Service.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Return to Work and QOL Following TBI. Impact of Rehabilitation Service.', 'orgStudyIdInfo': {'id': 'hovedtraume'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rehabilitation service', 'description': '* Centralized or Decentralized rehabilitation\n* Size of municipality', 'interventionNames': ['Other: Rehabilitation service']}], 'interventions': [{'name': 'Rehabilitation service', 'type': 'OTHER', 'description': '* Centralized/ decentralized hospital based rehabilitation defined as hospital based rehabilitation in a single or in multiple locations, respectively.\n* Size of the municipality responsible for providing rehabilitation services after discharge from hospital', 'armGroupLabels': ['Rehabilitation service']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8450', 'city': 'Hammel', 'country': 'Denmark', 'facility': 'Hammel Neurorehabilitation and Research Centre', 'geoPoint': {'lat': 56.25762, 'lon': 9.86316}}], 'overallOfficials': [{'name': 'Lene Odgaard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Unit (Forskningsenheden), Hammel Neurorehabilitation and Research Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}