Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT02602405
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2015-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Return to Work After Potential Severe Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1741}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to work', 'timeFrame': 'up to 8 years'}, {'measure': 'Return to education', 'timeFrame': 'up to 8 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Outcome Assessment (Health Care)', 'Return to work', 'Registries', 'Norway'], 'conditions': ['Multiple Trauma']}, 'referencesModule': {'references': [{'pmid': '30221344', 'type': 'DERIVED', 'citation': 'Uleberg O, Pape K, Kristiansen T, Romundstad PR, Klepstad P. Population-based analysis of the impact of trauma on longer-term functional outcomes. Br J Surg. 2019 Jan;106(1):65-73. doi: 10.1002/bjs.10965. Epub 2018 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'In Norway an estimated 10 % of the population is injured annually. Of these 36.000 sustain permanent functional impairment, 1.200 receive disability pension, and approximately 2.500 die because of their injuries. Mortality is the most common variable measuring trauma outcome. However, measuring only trauma mortality may be looking merely at the tip of the iceberg. For every trauma death, there are ten-folds suffering long term functional impairment. Mortality is therefore a too crude variable to describe the impact of injuries - both for the individual trauma patient and for society as a whole. There is a need for variables describing long-term outcomes on a functional level. The aim of this study is to use the rate of return to work and education as an alternative outcome measure. The ability of returning to work after injury is a central indicator of individual functional outcome, combining both physical and mental skills in performing complex and compound tasks. Previous studies on return to work after injury are limited by a combination of short follow-up times, the use of patient reported outcomes and having mainly been focusing on only severely injured patients (ISS \\> 15). This a population-based study including all patients in working age (16 - 65 years) received by a trauma team in any of the eight hospitals within the region of Central Norway in the time period from June 1st,2007 to May 30th, 2010. Already collected trauma registry data will be linked with national register data on sickness and disability benefits, employment and education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients in working age received by a trauma team in any of the eight hospitals within the region of Central Norway in the period from June 1st, 2007 to May 30th, 2010', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* exposed to traumatic injuries\n* received by trauma team attendance\n* received by trauma team activation protocol'}, 'identificationModule': {'nctId': 'NCT02602405', 'briefTitle': 'Return to Work After Potential Severe Injury', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Return to Work After Potential Severe Injury; a Population Based Observational Study', 'orgStudyIdInfo': {'id': '2015/1582'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ålesund', 'country': 'Norway', 'facility': 'Ålesund Hospital', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}, {'city': 'Kristiansund', 'country': 'Norway', 'facility': 'Kristiansund Hospital', 'geoPoint': {'lat': 63.11045, 'lon': 7.72795}}, {'city': 'Levanger', 'country': 'Norway', 'facility': 'Levanger Hospital', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}, {'city': 'Molde', 'country': 'Norway', 'facility': 'Molde Hospital', 'geoPoint': {'lat': 62.73752, 'lon': 7.15912}}, {'city': 'Namsos', 'country': 'Norway', 'facility': 'Namsos Hospital', 'geoPoint': {'lat': 64.46624, 'lon': 11.49572}}, {'city': 'Orkanger', 'country': 'Norway', 'facility': 'Orkanger Hospital', 'geoPoint': {'lat': 63.30668, 'lon': 9.85025}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Volda', 'country': 'Norway', 'facility': 'Volda Hospital', 'geoPoint': {'lat': 62.146, 'lon': 6.07108}}], 'overallOfficials': [{'name': 'Pål Klepstad, md prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'Statistics Norway', 'class': 'INDUSTRY'}, {'name': 'Namsos Hospital', 'class': 'OTHER'}, {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}, {'name': 'Alesund Hospital', 'class': 'OTHER'}, {'name': 'Molde Hospital', 'class': 'OTHER'}, {'name': 'Kristiansund Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}