Living With Spinal Cord Injury.
- Conditions
- Spinal Cord Injuries
- Interventions
- Other: no intervention
- Registration Number
- NCT03709732
- Lead Sponsor
- St. Olavs Hospital
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2654
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Controls for patients no intervention Control group for patient cohort. No intervention Spinal cord injury no intervention Persons with a spinal cord injury. No intervention Caregivers spinal cord injury no intervention Caregivers for persons with a spinal cord injury. No intervention
- Primary Outcome Measures
Name Time Method Work participation of persons with a spinal cord injury 2 years Before and after injury
Work participation of family caregivers 2 years Before and after their role as a caregiver
Mental Health of patients by MHI-5 2 years The mental Health is measured with the Mental Health Index (MHI-5)
Quality of life of patients by WHOQoL-5 2 years QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)
Quality of life of patients by ISCI QoL Data set 2 years QoL is measured with the International SCI quality of life Basic Data Set (ISCI QoL Data Set)
Mental health of family caregivers by MHI-5 2 years Mental health is measured with the Mental Health Index (MHI-5).
Quality of life of family caregivers by WHOQoL-5 2 years QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)
Quality of life of family caregivers by ISCI QoL Data Set 2 years QoL is measured with the International SCI quality of life Basic Data Set (ISCI QoL Data Set)
Caregiver burden by Caregiver strain index 2 years Caregiver burden for family caregivers is measured with the Caregiver strain index
Caregiver burden by Self rated burden scale 2 years Caregiver burden for family caregivers is measured with the Self rated burden scale.
Participation by PAM-13 for patients 2 years Participation is measured with the following instruments: Patient Activation Measure (PAM-13).
Participation by PAM-13 for family caregivers 2 years Participation is measured with the following instruments: Patient Activation Measure (PAM-13)
Participation by Utrecht scale for Evaluation of rehabilitation participation 2 years Participation for patients is measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).
Participation by Utrecht scale for Evaluation of rehabilitation participation (adjusted) 2 years Participation for family caregivers is measured with the adjusted Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St Olavs Hospital
🇳🇴Trondheim, Norway