Monitoring the Quality of Life of Patients With End-stage Renal Disease (QV-REIN)

NCT ID: NCT02890264

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2011-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

GUILLEMIN Francis, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serge BRIANCON

Role: PRINCIPAL_INVESTIGATOR

Central Hospital Nancy