Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-20 @ 6:43 PM
Study NCT ID:
NCT03709732
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2018-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Living With Spinal Cord Injury.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2654}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2018-10-15', 'studyFirstSubmitQcDate': '2018-10-15', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work participation of persons with a spinal cord injury', 'timeFrame': '2 years', 'description': 'Before and after injury'}, {'measure': 'Work participation of family caregivers', 'timeFrame': '2 years', 'description': 'Before and after their role as a caregiver'}, {'measure': 'Mental Health of patients by MHI-5', 'timeFrame': '2 years', 'description': 'The mental Health is measured with the Mental Health Index (MHI-5)'}, {'measure': 'Quality of life of patients by WHOQoL-5', 'timeFrame': '2 years', 'description': 'QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)'}, {'measure': 'Quality of life of patients by ISCI QoL Data set', 'timeFrame': '2 years', 'description': 'QoL is measured with the International SCI quality of life Basic Data Set (ISCI QoL Data Set)'}, {'measure': 'Mental health of family caregivers by MHI-5', 'timeFrame': '2 years', 'description': 'Mental health is measured with the Mental Health Index (MHI-5).'}, {'measure': 'Quality of life of family caregivers by WHOQoL-5', 'timeFrame': '2 years', 'description': 'QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)'}, {'measure': 'Quality of life of family caregivers by ISCI QoL Data Set', 'timeFrame': '2 years', 'description': 'QoL is measured with the International SCI quality of life Basic Data Set (ISCI QoL Data Set)'}, {'measure': 'Caregiver burden by Caregiver strain index', 'timeFrame': '2 years', 'description': 'Caregiver burden for family caregivers is measured with the Caregiver strain index'}, {'measure': 'Caregiver burden by Self rated burden scale', 'timeFrame': '2 years', 'description': 'Caregiver burden for family caregivers is measured with the Self rated burden scale.'}, {'measure': 'Participation by PAM-13 for patients', 'timeFrame': '2 years', 'description': 'Participation is measured with the following instruments: Patient Activation Measure (PAM-13).'}, {'measure': 'Participation by PAM-13 for family caregivers', 'timeFrame': '2 years', 'description': 'Participation is measured with the following instruments: Patient Activation Measure (PAM-13)'}, {'measure': 'Participation by Utrecht scale for Evaluation of rehabilitation participation', 'timeFrame': '2 years', 'description': 'Participation for patients is measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).'}, {'measure': 'Participation by Utrecht scale for Evaluation of rehabilitation participation (adjusted)', 'timeFrame': '2 years', 'description': 'Participation for family caregivers is measured with the adjusted Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of Life', 'Registries', 'Norway', 'Caregivers', 'Employment'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'A Spinal Cord Injury (SCI) often drastically disrupts the lives of affected patients and their relatives and caregivers. This observational study will provide new knowledge on how patients and their family caregivers cope in the first years after injury in terms of work inclusion, participation, care giver burden and quality of life. This project will utilize Norwegian spinal cord injury quality register data and link clinical individual data from the quality register to national administrative data on employment and social insurance benefits.', 'detailedDescription': 'All individuals in the Norwegian Spinal Cord Injury Registry (NorSCIR) in the period 2011-2017, meaning that they have already given their consent, will be asked to participate. They will be sent a letter with information about the study including a questionnaire.\n\nIn the letter they will also be asked, if they agree, to forward an invitation letter to their closest caregiver addressed to "the main family caregiver".\n\nMain family caregiver will be defined as persons who are providing unpaid assistance and support to the person with a SCI. The letter for the caregiver with information about the study, includes a questionnaire. All patients in the NorSCIR and their main caregivers (after consent) will be linked to national administrative register to provide data on social insurance benefits, education and work.\n\nControl groups from the general population will be selected and identified in the national registries (for both the patient cohort and caregiver cohort). These control groups will be used to compare the level of work/benefit over time for patients and caregivers with that of the general population. Also, within-person approaches will be used to assess the impact of the injury, comparing each participant\'s status in the period after injury with their own status at a time period before injury.\n\n20.04.2022 A relatively low proportion of family caregivers responded to the questionnaire (N = 73). Only 61 gave their consent to link their data to data from Statistics Norway and the Norwegian Labour and Welfare Administration. We had, therefore, to reconsider this part of the project. We have now concluded that the caregiver population is too small to link their information to the national administrative registers and to make a comparison with a control group from the general population. A control group for caregivers was therefore not needed anymore.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort 1:\n\nAll individuals in NorSCIR in the period 2011-2017, meaning that they have already given their consent, will be asked to participate.\n\nCohort 2:\n\nMain family caregiver will be defined as persons who are providing unpaid assistance and support to the person with a spinal cord injury.\n\nCohort 3 :\n\nA control group from the general population will be selected and identified in the national registries ( the patient cohort).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Cohort 1:\n\nInclusion criteria:\n\n* registered in the Norwegian spinal cord injury quality registry\n* giving informed consent, i.e. accept that the information in the registry (included linked information in national registers)\n\nExclusion criteria:\n\n* younger than 16 years\n\nCohort 2:\n\nInclusion criteria:\n\n* providing unpaid assistance and support to the person with a spinal cord injury\n* chosen by the patient.\n\nExclusion criteria:\n\n* younger than 16 years\n\nCohort 3 :\n\nInclusion:\n\n* Control groups from the general population, for patients\n* identified in the national registries\n\nExclusion criteria:\n\n* younger than 16 years'}, 'identificationModule': {'nctId': 'NCT03709732', 'briefTitle': 'Living With Spinal Cord Injury.', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Register Research Combined With Health Surveys and Patient Data, to Assess Work Participation and Quality of Life Among Persons With Spinal Cord Injury and Their Caregivers', 'orgStudyIdInfo': {'id': '2018/294'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal cord injury', 'description': 'Persons with a spinal cord injury. No intervention', 'interventionNames': ['Other: no intervention']}, {'label': 'Caregivers spinal cord injury', 'description': 'Caregivers for persons with a spinal cord injury. No intervention', 'interventionNames': ['Other: no intervention']}, {'label': 'Controls for patients', 'description': 'Control group for patient cohort. No intervention', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'observational study', 'armGroupLabels': ['Caregivers spinal cord injury', 'Controls for patients', 'Spinal cord injury']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Johan Skomsvoll, md phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olavs Hospital'}, {'name': 'Annette Halvorsen, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}