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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890264
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: September 6, 2016
• Start date: January 2005
• Est. completion date: December 2011

Study information

• Verified date: September 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Quality of Life
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life questionnaire for patients with end-stage renal disease		Every two years during six years	No
Secondary	mode of quality of life questionnaire administration		After one year of dialysis	No