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Completed

NCT Number: NCT03709732

Living With Spinal Cord Injury.

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Olavs Hospital

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

observational study

Primary outcomes

  1. Work participation of persons with a spinal cord injury

    Time frame: 2 years

    Before and after injury

  2. Work participation of family caregivers

    Time frame: 2 years

    Before and after their role as a caregiver

  3. Mental Health of patients by MHI-5

    Time frame: 2 years

    The mental Health is measured with the Mental Health Index (MHI-5)

  4. Quality of life of patients by WHOQoL-5

    Time frame: 2 years

    QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)

  5. Quality of life of patients by ISCI QoL Data set

    Time frame: 2 years

    QoL is measured with the International SCI quality of life Basic Data Set (ISCI QoL Data Set)

  6. Mental health of family caregivers by MHI-5

    Time frame: 2 years

    Mental health is measured with the Mental Health Index (MHI-5).

  7. Quality of life of family caregivers by WHOQoL-5

    Time frame: 2 years

    QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)

  8. Quality of life of family caregivers by ISCI QoL Data Set

    Time frame: 2 years

    QoL is measured with the International SCI quality of life Basic Data Set (ISCI QoL Data Set)

  9. Caregiver burden by Caregiver strain index

    Time frame: 2 years

    Caregiver burden for family caregivers is measured with the Caregiver strain index

  10. Caregiver burden by Self rated burden scale

    Time frame: 2 years

    Caregiver burden for family caregivers is measured with the Self rated burden scale.

  11. Participation by PAM-13 for patients

    Time frame: 2 years

    Participation is measured with the following instruments: Patient Activation Measure (PAM-13).

  12. Participation by PAM-13 for family caregivers

    Time frame: 2 years

    Participation is measured with the following instruments: Patient Activation Measure (PAM-13)

  13. Participation by Utrecht scale for Evaluation of rehabilitation participation

    Time frame: 2 years

    Participation for patients is measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).

  14. Participation by Utrecht scale for Evaluation of rehabilitation participation (adjusted)

    Time frame: 2 years

    Participation for family caregivers is measured with the adjusted Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 17, 2018
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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