Living With Spinal Cord Injury.

April 20, 2022 updated by: St. Olavs Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2654

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Work participation of persons with a spinal cord injury
Time Frame: 2 years
Before and after injury
2 years
Work participation of family caregivers
Time Frame: 2 years
Before and after their role as a caregiver
2 years
Mental Health of patients by MHI-5
Time Frame: 2 years
The mental Health is measured with the Mental Health Index (MHI-5)
2 years
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)
2 years
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)
2 years
Mental health of family caregivers by MHI-5
Time Frame: 2 years
Mental health is measured with the Mental Health Index (MHI-5).
2 years
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)
2 years
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)
2 years
Caregiver burden by Caregiver strain index
Time Frame: 2 years
Caregiver burden for family caregivers is measured with the Caregiver strain index
2 years
Caregiver burden by Self rated burden scale
Time Frame: 2 years
Caregiver burden for family caregivers is measured with the Self rated burden scale.
2 years
Participation by PAM-13 for patients
Time Frame: 2 years
Participation is measured with the following instruments: Patient Activation Measure (PAM-13).
2 years
Participation by PAM-13 for family caregivers
Time Frame: 2 years
Participation is measured with the following instruments: Patient Activation Measure (PAM-13)
2 years
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).
2 years
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).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Olavs Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Johan Skomsvoll, md phd, St. Olavs hospital
  • Principal Investigator: Annette Halvorsen, md, St. Olavs hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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