Quality of LifeNCT02890264
Monitoring the Quality of Life of Patients With End-stage Renal Disease (QV-REIN)
An observational study of Quality of Life, run by Central Hospital, Nancy, France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Quality of Life
- Keywords
- End stage renal disease, Dialysis
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life questionnaire for patients with end-stage renal disease
Measured: Every two years during six years
Secondary outcomes (1)
mode of quality of life questionnaire administration
Measured: After one year of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJan 2005
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUILLEMIN Francis, MD, Central Hospital, Nancy, France
- Investigators
- Serge BRIANCON, Principal investigator, Central Hospital Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890264
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Quality of Life of Patients With End-stage Renal Disease (QV-REIN) - Dialysis
- ClinicalTrials.gov ID
- NCT02890264
- Conditions
- Quality of Life
- Keywords
- End stage renal disease, Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
quality of life questionnaire for patients with end-stage renal disease
Time frame: Every two years during six years
1 secondary outcome
mode of quality of life questionnaire administration
Time frame: After one year of dialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge BRIANCON principal investigator
Central Hospital Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life questionnaire for patients with end-stage renal disease (time frame: Every two years during six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.