Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus

Lupus Erythematosus Clinical Trial

— EQUAL  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904812
• Other study ID #: Besancenot PHRC N 2010
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: May 2015

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• - Patients meeting ACR 1997 classification criteria for systemic lupus erythematosus.

• Patients able to understand written and spoken French.

• Patients aged from 18 to 75 years

• Patients who have received written and oral information about the research.

Exclusion Criteria:

• - Patients aged less than 18 years

• Patients aged more than 75 years

• Severe mental retardation Any impairment of abilities to understand that make self-evaluation impossible

Related Conditions & MeSH terms

• Lupus Erythematosus
• Lupus Erythematosus, Systemic

Intervention

Other:
• Questionnaire about quality of life and satisfaction

Locations

Country	Name	City	State
France	CHU de Dijon	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	data for quality of life and satisfaction	Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20	participants will be followed for the duration of hospital stay, an expected average of 3 months
Secondary	Clinical data	Question about any recent hospitalization pregnancy contraception Compliance score of Girerd Fatigue score MFI-20 tobacco consumption Score of CES-D depression Score stress response WCC	participants will be followed for the duration of hospital stay, an expected average of 3 months