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

August 2, 2016 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ)
Time Frame: Evolution of answers between D0, D15, M3 and M6
Evolution of answers between D0, D15, M3 and M6

Secondary Outcome Measures

Outcome Measure
Time Frame
Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire
Time Frame: Evolution of answers between D0, D15, M3 and M6
Evolution of answers between D0, D15, M3 and M6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DEVILLIERS 189 HORS AOI 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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