Monitoring the Quality of Life of Patients With End-stage Renal Disease (QV-REIN) - Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 主要终点
- quality of life questionnaire for patients with end-stage renal disease
研究概览
简要总结
The main purpose for holding this survey is epidemiological surveillance, it must provide the indicators that contribute to the evaluation of the plan "improvement of the quality of life in chronic diseases" and monitoring the goal of 81 health law public in August 2004. This survey is intended to be renewed during the implementation period of the public health law to provide plan monitoring indicators.
The main objective is : To describe the quality of life of patients with major end-stage renal disease treated with dialysis method for at least one year.
The seconds objectives are :
- To contribute to the knowledge of the key determinants of the quality of life among chronic renal failure patients.
- To study the influence on way of giving a questionnaire about assessment of level of quality of life
详细描述
The proposed scheme is that of a repeated cross-sectional survey, with prevalent patients dialysis for at least 1 year, by self-administered questionnaires using standardized instruments and passed among a representative sample of subjects included in the nine participating regions kidney system. The first study in 2005, it is required to be repeated during the plan period (theoretically in 2007, 2009 and 2011).
Three studies will be carried out between 2005 and 2010. The progress of each study is the same.
The random draw of eligible patients, according to a stratification by region and age group is carried out by the Biostatistics and Medical Informatics Service of the Necker Hospital in Paris, responsible for basic SIMS-REIN, for data center in the regions Champagne-Ardenne, Languedoc-Roussillon, Limousin and Provence-Alpes-Côte d'Azur. For Auvergne, Bretagne, Lorraine and Rhône-Alpes, which operate independently for the collection of data REIN, the random draw of patients is done by each epidemiological center responsible for this collection.
The Biostatistics and Medical Informatics Service of the Necker Hospital, and epidemiological centers of Auvergne, Bretagne, Lorraine and Rhône Alpes must submit the list of selected patients Clinical Research Associate (CRA) national.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient prevalent dialysis for at least 1 year
- •Age at least 18 years old at the time of dialysis at
- •Treaty within one of the nine aforementioned regions
排除标准
- 未提供
结局指标
主要结局
quality of life questionnaire for patients with end-stage renal disease
时间窗: Every two years during six years
次要结局
- mode of quality of life questionnaire administration(After one year of dialysis)
研究者
GUILLEMIN Francis, MD
Professor
Central Hospital, Nancy, France