Quality of Life Clinical Trial
Official title:
Monitoring the Quality of Life of Patients With End-stage Renal Disease (QV-REIN) - Dialysis
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
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.
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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