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

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ClinicalTrials.gov Identifier: NCT02890264
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
GUILLEMIN Francis, MD, Central Hospital, Nancy, France

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
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.

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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 : January 2005
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. quality of life questionnaire for patients with end-stage renal disease [ Time Frame: Every two years during six years ]

Secondary Outcome Measures :
  1. mode of quality of life questionnaire administration [ Time Frame: After one year of dialysis ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890264


Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Serge BRIANCON Central Hospital Nancy
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Responsible Party: GUILLEMIN Francis, MD, Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02890264    
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GUILLEMIN Francis, MD, Central Hospital, Nancy, France:
End stage renal disease
Dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency