Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2654 participants
OBSERVATIONAL
2019-06-13
2021-07-30
Brief Summary
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Detailed Description
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In 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".
Main 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.
Control 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.
20.04.2022 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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Spinal cord injury
Persons with a spinal cord injury. No intervention
no intervention
observational study
Caregivers spinal cord injury
Caregivers for persons with a spinal cord injury. No intervention
no intervention
observational study
Controls for patients
Control group for patient cohort. No intervention
no intervention
observational study
Interventions
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no intervention
observational study
Eligibility Criteria
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Inclusion Criteria
* giving informed consent, i.e. accept that the information in the registry (included linked information in national registers)
* providing unpaid assistance and support to the person with a spinal cord injury
* chosen by the patient.
Exclusion Criteria
Cohort 2:
* younger than 16 years
Cohort 3 :
Inclusion:
* Control groups from the general population, for patients
* identified in the national registries
* younger than 16 years
16 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Johan Skomsvoll, md phd
Role: STUDY_DIRECTOR
St. Olavs Hospital
Annette Halvorsen, md
Role: PRINCIPAL_INVESTIGATOR
St. Olavs Hospital
Locations
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St Olavs Hospital
Trondheim, , Norway
Countries
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Other Identifiers
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2018/294
Identifier Type: -
Identifier Source: org_study_id
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