Living With Spinal Cord Injury.

NCT03709732 | Completed

• 1 other identifier: 2018/294
• Study Type: observational
• Target: 2,654
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Quality of Life; Registries; Norway; Caregivers; Employment

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (3)

Spinal cord injury

Persons with a spinal cord injury. No intervention

Other: no intervention

Caregivers spinal cord injury

Caregivers for persons with a spinal cord injury. No intervention

Other: no intervention

Controls for patients

Control group for patient cohort. No intervention

Other: no intervention

Interventions

no intervention OTHER

observational study

Caregivers spinal cord injury; Controls for patients; Spinal cord injury

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• younger than 16 years
• Cohort 2:
• providing unpaid assistance and support to the person with a spinal cord injury
• chosen by the patient.
• younger than 16 years
• Cohort 3 :
• Control groups from the general population, for patients
• identified in the national registries
• younger than 16 years

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Johan Skomsvoll, md phd

  St. Olavs Hospital

  STUDY DIRECTOR

• Annette Halvorsen, md

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: June 13, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

NO (1)