Multicentre Prospective Observational Study for Identification of Determinants of Disability and Quality of Life in Patients With Gout.
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
- 否
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
Carlo Alberto Scire
MD, PhD, Coordinator of the Epidemiology Unit - SIR
Italian Society for Rheumatology
