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Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus (EQUAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904812
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
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Brief Summary:
Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus Other: Questionnaire about quality of life and satisfaction Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Actual Study Start Date : December 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Lupus erythematosus Other: Questionnaire about quality of life and satisfaction


Outcome Measures
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Primary Outcome Measures :
  1. data for quality of life and satisfaction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 months ]
    Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20


Secondary Outcome Measures :
  1. Clinical data [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 months ]
    Question about any recent hospitalization pregnancy contraception Compliance score of Girerd Fatigue score MFI-20 tobacco consumption Score of CES-D depression Score stress response WCC


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Patients meeting ACR 1997 classification criteria for systemic lupus erythematosus.
  • Patients able to understand written and spoken French.
  • Patients aged from 18 to 75 years
  • Patients who have received written and oral information about the research.

Exclusion Criteria:

  • - Patients aged less than 18 years
  • Patients aged more than 75 years
  • Severe mental retardation Any impairment of abilities to understand that make self-evaluation impossible
Contacts and Locations
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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): NCT01904812


Locations
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France
CHU de Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
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Principal Investigator: Jean-François BESANCENOT CHU Dijon - Department of Internal Medicine and Systemic Diseases
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01904812    
Other Study ID Numbers: Besancenot PHRC N 2010
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: July 2013
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases