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临床试验/NCT02879890
NCT02879890已完成不适用

Impact of Comorbidities on Measure of Indirect Utility Change in Hip and Knee Ostearthritis

Central Hospital, Nancy, France0 个研究点目标入组 878 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
878
主要终点
Change in health utility state

研究概览

简要总结

National cohort study aimed to investigate the impact of comorbidities (number and type of comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).

详细描述

The concept of health utility state was developed by economists to explain individual choices and preferences for health states. It is expressed as the "desirability or preference that individuals exhibit for the condition". This health utility state can be measured indirectly using health-relation quality of life questionnaires.

Chronic diseases such as OA are known to be associated with impairment of quality of life. Given that OA prevalence increases with age, OA is often associated with other diseases (comorbidities). A cross-sectional study showed that comorbidities are associated with lower health utility state in OA. Investigation of longitudinal impact of comorbidities on health utility state change is need.

Main objective: Determine the impact of comorbidities on change in health utility state among patients with lower limb OA.

Secondary objective: Determine the Minimal Clinically important Difference in health utility state among patients with lower limb OA.

The COMUTAR study uses longitudinal data from the Knee and Hip Osteoarthritis Longitudinal Assessment (KHOALA) cohort study. Health utility state is measured indirectly using Medical Outcome Study Short Form-36 quality of life questionnaire Comorbidities are assessed using the Functional Comorbidity Index

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age: 40-75 years
  • Uni or bilateral lower limb osteoarthritis (OA) according to the American College of Rheumatology (ACR) and European league against rheumatism (EULAR) criteria

排除标准

  • Hip or knee prothesis
  • Antecedent of osteotomy
  • Severe comorbidity
  • Adult under legal protection

结局指标

主要结局

Change in health utility state

时间窗: Five years

Change in health state utility score between the inclusion in the KHOALA cohort and 5 years later (T5-T0)

次要结局

  • Minimal Clinically Important Difference (MCID) of health utility state(Five years)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

GUILLEMIN Francis, MD

Professor

Central Hospital, Nancy, France

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