Overview

This trial is active, not recruiting.

Condition lupus erythematosus
Treatment questionnaire about quality of life and satisfaction
Sponsor Centre Hospitalier Universitaire Dijon
Start date December 2011
End date January 2015
Trial size 356 participants
Trial identifier NCT01904812, Besancenot PHRC N 2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Other)
questionnaire about quality of life and satisfaction

Primary Outcomes

Measure
data for quality of life and satisfaction
time frame: participants will be followed for the duration of hospital stay, an expected average of 3 months

Secondary Outcomes

Measure
Clinical data
time frame: participants will be followed for the duration of hospital stay, an expected average of 3 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Principal investigator Jean-François BESANCENOT
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire Dijon.