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CompletedNCT02857452FRESH COLAUpdated Aug 5, 2016

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

An observational study in Lupus, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-05.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
162
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lupus
03

In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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

Exclusion Criteria:

  • Severe mental retardation.
  • Any impairment of ability to understand making self-evaluation impossible.
  • Age \< 18 years.
  • Age > 75 years.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
162 participants (actual)
Patient registry
No

Groups and cohorts

  • Lupus

    Other: SLA Questionnaire · Other: Lupus Qol Questionnaire

Interventions

  • OtherSLA Questionnaire
  • OtherLupus Qol Questionnaire
06

What researchers measure

Primary outcomes

  1. Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ)

    Time frame: Evolution of answers between D0, D15, M3 and M6

Secondary outcomes

  1. Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire

    Time frame: Evolution of answers between D0, D15, M3 and M6

07

Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02857452
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 5, 2016
Start date
Jan 2009
Primary completion
Feb 2010
Last update
Aug 5, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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