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临床试验/NCT02508675
NCT02508675Unknown不适用

Prevalence, Recovery Patterns and Risk Factors of Non-fatal Outcome and Costs After Trauma; a Prospective Follow up Study

Network Emergency Care Brabant0 个研究点目标入组 6,500 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
6,500
主要终点
Healthcare and societal costs

研究概览

简要总结

The major aim of this project is to investigate the prevalence, recovery patterns and risk factors for health related quality of life functional, psychological, societal and economic outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref) questionnaire for the trauma population.

详细描述

Patients aged 18 years and older admitted in a hospital in Brabant after a trauma, independent of severity or type of injury are included in the study. Patients who decease during hospital stay or transferred to another hospital outside the borders of trauma region Brabant will be excluded. Socio-demographic characteristics, functional and psychological outcome and Health Related Quality of Life (HRQoL) shortly after trauma will be measured. Subsequently the same items will be measured after 1, 3, 6, 12 and 24 months. Outcomes will be assessed using questionnaires. The primary outcome parameters are: short and long term HRQoL, functional and psychological outcome, and Healthcare and societal costs in injured patients. Secondary outcome measures are Return to Work and health care consumption.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients seen at the ED which are admitted to the ICU or ward after getting injured
  • all types and severities of injury (Injury Severity Score (ISS) 1-75)
  • a minimal age of 18 years old
  • sufficient knowledge of the Dutch language

排除标准

  • patients who are dead on arrival or decease in the ED
  • pathological fracture (i.e., the bones are weakened by disease, for example by a tumor)
  • patients who die in the hospital will drop out the study and will not be included in the analyses

结局指标

主要结局

Healthcare and societal costs

时间窗: 2 years

self-reported questionnaire and information from registries

Short and longterm HRQoL

时间窗: 2 years

self-reported questionnaire

Functional outcome

时间窗: 2 years

self-reported questionnaire

Psychological outcome

时间窗: 2 years

self-reported questionnaire

Social outcome

时间窗: 2 years

self-reported questionnaire

次要结局

  • Return to work (RtW)(2 years)
  • Health care consumption(2 years)

研究者

发起方
Network Emergency Care Brabant
申办方类型
Other
责任方
Sponsor

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