Clinical trial NCT03709732: Living With Spinal Cord Injury.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: Quality of Life
Registries
Norway
Caregivers
Employment
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2018-10-17
Enrollment: 2654
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort 1:

All individuals in NorSCIR in the period 2011-2017, meaning that they have already given their consent, will be asked to participate.

Cohort 2:

Main family caregiver will be defined as persons who are providing unpaid assistance and support to the person with a spinal cord injury.

Cohort 3 :

A control group from the general population will be selected and identified in the national registries ( the patient cohort).

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.

Eligibility criteria: Cohort 1:

Inclusion criteria:

* registered in the Norwegian spinal cord injury quality registry
* giving informed consent, i.e. accept that the information in the registry (included linked information in national registers)

Exclusion criteria:

* younger than 16 years

Cohort 2:

Inclusion criteria:

* providing unpaid assistance and support to the person with a spinal cord injury
* chosen by the patient.

Exclusion criteria:

* younger than 16 years

Cohort 3 :

Inclusion:

* Control groups from the general population, for patients
* identified in the national registries

Exclusion criteria:

* younger than 16 years

Primary outcomes:
measure: Work participation of persons with a spinal cord injury
timeFrame: 2 years
measure: Work participation of family caregivers
timeFrame: 2 years
measure: Mental Health of patients by MHI-5
timeFrame: 2 years
measure: Quality of life of patients by WHOQoL-5
timeFrame: 2 years
measure: Quality of life of patients by ISCI QoL Data set
timeFrame: 2 years
measure: Mental health of family caregivers by MHI-5
timeFrame: 2 years
measure: Quality of life of family caregivers by WHOQoL-5
timeFrame: 2 years
measure: Quality of life of family caregivers by ISCI QoL Data Set
timeFrame: 2 years
measure: Caregiver burden by Caregiver strain index
timeFrame: 2 years
measure: Caregiver burden by Self rated burden scale
timeFrame: 2 years
measure: Participation by PAM-13 for patients
timeFrame: 2 years
measure: Participation by PAM-13 for family caregivers
timeFrame: 2 years
measure: Participation by Utrecht scale for Evaluation of rehabilitation participation
timeFrame: 2 years
measure: Participation by Utrecht scale for Evaluation of rehabilitation participation (adjusted)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Johan Skomsvoll, md phd
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital
name: Annette Halvorsen, md
role: PRINCIPAL_INVESTIGATOR
References: