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临床试验/NCT01549210
NCT01549210已完成不适用

Multicentre Prospective Observational Study for Identification of Determinants of Disability and Quality of Life in Patients With Gout.

Italian Society for Rheumatology1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2011年4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
450
试验地点
1
主要终点
Functional disability

研究概览

简要总结

The study aims to identify which characteristics are associated with disability and poor quality of life in patients suffering from gout. This is a multicentre prospective observational study carried out in a cohort of Italian patients with gout. Subjects are randomly selected from a list of patients referred to each participant rheumatology clinic in the previous 2 years. Clinical evaluations are performed at baseline, at 6 and 12 months; data are retrieved about sociodemographic variables, life-styles, history of gout, comorbidities and patterns of treatment. At each visit patients complete questionnaires assessing disability and health-related quality of life. Preplanned analyses will be performed to investigate predictors of disability and poor quality of life in these patients.

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

  • Clinical diagnosis of gout
  • Must be able to understand questionnaires

排除标准

  • Diagnosis not validated by rheumatologist
  • Not able to sign informed consent

结局指标

主要结局

Functional disability

时间窗: 1 year

Health Assessment Questionnaire Disability Index (HAQ-DI)

次要结局

  • Health-related quality of life(1 year)

研究者

发起方
Italian Society for Rheumatology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Alberto Scire

MD, PhD, Coordinator of the Epidemiology Unit - SIR

Italian Society for Rheumatology

研究点 (1)

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