Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03709732
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2018-10-15
Brief Title:
Living With Spinal Cord Injury
Sponsor:
St Olavs Hospital
Organization:
St Olavs Hospital
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 workbenefit 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 participants status in the period after injury with their own status at a time period before injury
20042022 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
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 workbenefit 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 participants status in the period after injury with their own status at a time period before injury
20042022 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None