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OpenTrials
Completed

NCT Number: NCT02857452

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SLA Questionnaire

Other

Lupus Qol Questionnaire

Other

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: FRESH COLA

Important dates

Study start
2009
Primary completion
2010
First posted
Aug 5, 2016
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.