Spinal Cord InjuriesNCT03709732
Living With Spinal Cord Injury.
An observational study of Spinal Cord Injuries, run by St. Olavs Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 2,654 participants
- Where
- 1 siteNorway
- Study dates
- 13 Jun 2019to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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)
- providing unpaid assistance and support to the person with a spinal cord injury
- chosen by the patient.
- Control groups from the general population, for patients
- identified in the national registries
Who cannot join
- younger than 16 years
- Cohort 2:
- younger than 16 years
- Cohort 3 :
- younger than 16 years
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- no intervention
- Keywords
- Quality of Life, Registries, Norway, Caregivers, Employment
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord injury | Persons with a spinal cord injury. No intervention Receives: Other: no intervention | |
| Caregivers spinal cord injury | Caregivers for persons with a spinal cord injury. No intervention Receives: Other: no intervention | |
| Controls for patients | Control group for patient cohort. No intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work participation of persons with a spinal cord injury
Before and after injury
Measured: 2 years
Work participation of family caregivers
Before and after their role as a caregiver
Measured: 2 years
Mental Health of patients by MHI-5
The mental Health is measured with the Mental Health Index (MHI-5)
Measured: 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)
Measured: 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)
Measured: 2 years
Mental health of family caregivers by MHI-5
Mental health is measured with the Mental Health Index (MHI-5).
Measured: 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)
Measured: 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)
Measured: 2 years
Caregiver burden by Caregiver strain index
Caregiver burden for family caregivers is measured with the Caregiver strain index
Measured: 2 years
Caregiver burden by Self rated burden scale
Caregiver burden for family caregivers is measured with the Self rated burden scale.
Measured: 2 years
Participation by PAM-13 for patients
Participation is measured with the following instruments: Patient Activation Measure (PAM-13).
Measured: 2 years
Participation by PAM-13 for family caregivers
Participation is measured with the following instruments: Patient Activation Measure (PAM-13)
Measured: 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).
Measured: 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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start13 Jun 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,654 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Johan Skomsvoll, md phd, Study director, St. Olavs HospitalAnnette Halvorsen, md, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709732
- Sponsor's protocol ID
- 2018/294
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2018
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03709732
- Acronym / sponsor ID
- 2018/294
- Conditions
- Spinal Cord Injuries
- Keywords
- Quality of Life, Registries, Norway, Caregivers, Employment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,654 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injury | – | Other: no interventionPersons with a spinal cord injury. No intervention |
| Caregivers spinal cord injury | – | Other: no interventionCaregivers for persons with a spinal cord injury. No intervention |
| Controls for patients | – | Other: no interventionControl group for patient cohort. No intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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)
- providing unpaid assistance and support to the person with a spinal cord injury
- chosen by the patient.
- Control groups from the general population, for patients
Key exclusion criteria (5 listed)
- younger than 16 years
- younger than 16 years
- younger than 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionobservational study | Other | Caregivers spinal cord injury, Controls for patients, Spinal cord injury |
Primary outcome
Work participation of persons with a spinal cord injury
Time frame: 2 years
Before and after injury
Work participation of family caregivers
Time frame: 2 years
Before and after their role as a caregiver
Mental Health of patients by MHI-5
Time frame: 2 years
The mental Health is measured with the Mental Health Index (MHI-5)
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)
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)
Mental health of family caregivers by MHI-5
Time frame: 2 years
Mental health is measured with the Mental Health Index (MHI-5).
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)
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)
Caregiver burden by Caregiver strain index
Time frame: 2 years
Caregiver burden for family caregivers is measured with the Caregiver strain index
Caregiver burden by Self rated burden scale
Time frame: 2 years
Caregiver burden for family caregivers is measured with the Self rated burden scale.
Participation by PAM-13 for patients
Time frame: 2 years
Participation is measured with the following instruments: Patient Activation Measure (PAM-13).
Participation by PAM-13 for family caregivers
Time frame: 2 years
Participation is measured with the following instruments: Patient Activation Measure (PAM-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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Skomsvoll, md phd study director
St. Olavs Hospital
Annette Halvorsen, md principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work participation of persons with a spinal cord injury (time frame: 2 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.