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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT02890264
Collaborator
(none)
1,000
83

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Monitoring the Quality of Life of Patients With End-stage Renal Disease (QV-REIN) - Dialysis
    Study Start Date :
    Jan 1, 2005
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. quality of life questionnaire for patients with end-stage renal disease [Every two years during six years]

    Secondary Outcome Measures

    1. mode of quality of life questionnaire administration [After one year of dialysis]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Principal Investigator: Serge BRIANCON, Central Hospital Nancy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GUILLEMIN Francis, MD, Professor, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT02890264
    Other Study ID Numbers:
      First Posted:
      Sep 7, 2016
      Last Update Posted:
      Sep 7, 2016
      Last Verified:
      Sep 1, 2016
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Keywords provided by GUILLEMIN Francis, MD, Professor, Central Hospital, Nancy, France
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Sep 7, 2016