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

Lupus Clinical Trial

— FRESH COLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857452
• Other study ID #: DEVILLIERS 189 HORS AOI 2008
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 2, 2016
• Start date: January 2009

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus
• Lupus Erythematosus, Systemic

Intervention

Other:
• SLA Questionnaire

• Lupus Qol Questionnaire

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ)		Evolution of answers between D0, D15, M3 and M6	No
Secondary	Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire		Evolution of answers between D0, D15, M3 and M6	No