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Trial record 22 of 314 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Living With Spinal Cord Injury.

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ClinicalTrials.gov Identifier: NCT03709732
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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.


Study Type : Observational
Estimated Enrollment : 4500 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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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

Controls for caregivers
Control group for caregivers cohort. No intervention
Other: no intervention
observational study




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. Quality of life of patients according WHOQOL-BREF [ Time Frame: 2 years ]
    The WHOQOL-BREF (24) is a 26-item, cross culturally valid QOL questionnaire with 4 QOL domains: physical health, psychological health, social relationships, and environment

  4. Quality of life of family caregivers according WHOQOL-BREF [ Time Frame: 2 years ]
    The WHOQOL-BREF (24) is a 26-item, cross culturally valid QOL questionnaire with 4 QOL domains: physical health, psychological health, social relationships, and environment

  5. Caregiver burden [ Time Frame: 2 years ]
    22-item questionnaire to measure the subjective burden of caregivers in five domains (general strain, isolation, disappointment, emotional involvement, and environment)



Information from the National Library of Medicine

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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 and 4:

Control groups from the general population will be selected and identified in the national registries (for both the patient cohort and caregiver 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 and 4:

Inclusion:

  • Control groups from the general population, for both patients and caregivers
  • identified in the national registries

Exclusion criteria:

  • younger than 16 years

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


Contacts
Contact: Annette Halvorsen, md +47 99295499 annette.halvorsen@stolav.no
Contact: Aslak Steinsbekk, phd prof aslak.steinsbekk@ntnu.no

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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03709732     History of Changes
Other Study ID Numbers: 2018/294
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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