Living With Spinal Cord Injury.

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Observational
• Enrollment (Actual): 2654

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spinal cord injury; Persons with a spinal cord injury. No intervention	Other: no intervention; observational study
Caregivers spinal cord injury; Caregivers for persons with a spinal cord injury. No intervention	Other: no intervention; observational study
Controls for patients; Control group for patient cohort. No intervention	Other: no intervention; observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work participation of persons with a spinal cord injury	Before and after injury	2 years
Work participation of family caregivers	Before and after their role as a caregiver	2 years
Mental Health of patients by MHI-5	The mental Health is measured with the Mental Health Index (MHI-5)	2 years
Quality of life of patients by WHOQoL-5	QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)	2 years
Quality of life of patients by ISCI QoL Data set	QoL is measured with the International SCI quality of life Basic Data Set (ISCI QoL Data Set)	2 years
Mental health of family caregivers by MHI-5	Mental health is measured with the Mental Health Index (MHI-5).	2 years
Quality of life of family caregivers by WHOQoL-5	QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)	2 years
Quality of life of family caregivers by ISCI QoL Data Set	QoL is measured with the International SCI quality of life Basic Data Set (ISCI QoL Data Set)	2 years
Caregiver burden by Caregiver strain index	Caregiver burden for family caregivers is measured with the Caregiver strain index	2 years
Caregiver burden by Self rated burden scale	Caregiver burden for family caregivers is measured with the Self rated burden scale.	2 years
Participation by PAM-13 for patients	Participation is measured with the following instruments: Patient Activation Measure (PAM-13).	2 years
Participation by PAM-13 for family caregivers	Participation is measured with the following instruments: Patient Activation Measure (PAM-13)	2 years
Participation by Utrecht scale for Evaluation of rehabilitation participation	Participation for patients is measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).	2 years
Participation by Utrecht scale for Evaluation of rehabilitation participation (adjusted)	Participation for family caregivers is measured with the adjusted Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).	2 years

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Study Director: Johan Skomsvoll, md phd, St. Olavs hospital; Principal Investigator: Annette Halvorsen, md, St. Olavs hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Caregivers; Employment; Registries; Norway
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 2018/294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No