We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Living With Spinal Cord Injury.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709732
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Spinal Cord Injuries 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 2654 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : June 13, 2019
Actual Primary Completion Date : July 30, 2021
Actual Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709732


Locations
Layout table for location information
Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Layout table for investigator information
Study Director: Johan Skomsvoll, md phd St. Olavs Hospital
Principal Investigator: Annette Halvorsen, md St. Olavs Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03709732    
Other Study ID Numbers: 2018/294
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Quality of Life
Registries
Norway
Caregivers
Employment
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System