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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,654
- 试验地点
- 1
- 主要终点
- Work participation of persons with a spinal cord injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Work participation of persons with a spinal cord injury
时间窗: 2 years
Before and after injury
Work participation of family caregivers
时间窗: 2 years
Before and after their role as a caregiver
Mental Health of patients by MHI-5
时间窗: 2 years
The mental Health is measured with the Mental Health Index (MHI-5)
Quality of life of patients by WHOQoL-5
时间窗: 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
时间窗: 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
时间窗: 2 years
Mental health is measured with the Mental Health Index (MHI-5).
Quality of life of family caregivers by WHOQoL-5
时间窗: 2 years
QoL is measured with the 5-item World Health Organization Quality of Life Assessment (WHOQoL-5)
Participation by Utrecht scale for Evaluation of rehabilitation participation
时间窗: 2 years
Participation for patients is measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).
Quality of life of family caregivers by ISCI QoL Data Set
时间窗: 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
时间窗: 2 years
Caregiver burden for family caregivers is measured with the Caregiver strain index
Caregiver burden by Self rated burden scale
时间窗: 2 years
Caregiver burden for family caregivers is measured with the Self rated burden scale.
Participation by Utrecht scale for Evaluation of rehabilitation participation (adjusted)
时间窗: 2 years
Participation for family caregivers is measured with the adjusted Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P).
Participation by PAM-13 for patients
时间窗: 2 years
Participation is measured with the following instruments: Patient Activation Measure (PAM-13).
Participation by PAM-13 for family caregivers
时间窗: 2 years
Participation is measured with the following instruments: Patient Activation Measure (PAM-13)
次要结局
未报告次要终点