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

Not Applicable

Completed

• Conditions: Lupus Erythematosus
• Interventions: Other: Questionnaire about quality of life and satisfaction

• Registration Number: NCT01904812
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Status Verified: 2013-07
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-22
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lupus erythematosus	Questionnaire about quality of life and satisfaction	-

Primary Outcome Measures

Name	Time	Method
data for quality of life and satisfaction	participants will be followed for the duration of hospital stay, an expected average of 3 months	Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20

Secondary Outcome Measures

Name	Time	Method
Clinical data	participants will be followed for the duration of hospital stay, an expected average of 3 months	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

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France