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

September 6, 2016 updated by: GUILLEMIN Francis, MD, Central Hospital, Nancy, France

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The source population is all patients included in the REIN system at the time of the survey in the nine participating regions currently in the system: Auvergne, Bretagne, Centre, Champagne Ardennes, Languedoc Roussillon, Limousin, Lorraine, Provence Alpes Côte d 'Azur, Rhône Alpes.

The patients selected to participate in the study were selected by random draw on all of the base, from those whose annual spot date falls during the investigation period.

The random draw is stratified by region and age group with a sampling fraction proportional to the size of the original population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life questionnaire for patients with end-stage renal disease
Time Frame: Every two years during six years
Every two years during six years

Secondary Outcome Measures

Outcome Measure
Time Frame
mode of quality of life questionnaire administration
Time Frame: After one year of dialysis
After one year of dialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Serge BRIANCON, Central Hospital Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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