NCT02890264

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

5.9 years

First QC Date

August 29, 2016

Last Update Submit

September 6, 2016

Conditions

Keywords

End stage renal diseaseDialysis

Outcome Measures

Primary Outcomes (1)

  • quality of life questionnaire for patients with end-stage renal disease

    Every two years during six years

Secondary Outcomes (1)

  • mode of quality of life questionnaire administration

    After one year of dialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Serge BRIANCON

    Central Hospital Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 7, 2016

Study Start

January 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

September 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share