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Trial record 2 of 896 for:    Lupus

Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire (FRESH COLA)

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ClinicalTrials.gov Identifier: NCT02857452
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life.

The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. It has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. It has never been validated in French. The Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients.

This tool, validated in a British population, has never been validated in French.


Condition or disease Intervention/treatment
Lupus Other: SLA Questionnaire Other: Lupus Qol Questionnaire

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Study Type : Observational
Actual Enrollment : 162 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire
Study Start Date : January 2009
Actual Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort Intervention/treatment
Lupus Other: SLA Questionnaire
Other: Lupus Qol Questionnaire



Primary Outcome Measures :
  1. Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ) [ Time Frame: Evolution of answers between D0, D15, M3 and M6 ]

Secondary Outcome Measures :
  1. Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire [ Time Frame: Evolution of answers between D0, D15, M3 and M6 ]


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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
Sampling Method:   Non-Probability Sample
Study Population
Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous
Criteria

Inclusion Criteria:

  • Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous.
  • Patients able to understand written and spoken French.
  • Patients who have been informed about the research

Exclusion Criteria:

  • Severe mental retardation.
  • Any impairment of ability to understand making self-evaluation impossible.
  • Age < 18 years.
  • Age > 75 years.

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): NCT02857452


Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02857452     History of Changes
Other Study ID Numbers: DEVILLIERS 189 HORS AOI 2008
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases