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

NCT01904812 | Completed

• 1 other identifier: Besancenot PHRC N 2010
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical data

  participants will be followed for the duration of hospital stay, an expected average of 3 months

Study Arms (1)

Lupus erythematosus

OTHER

Other: Questionnaire about quality of life and satisfaction

Interventions

Questionnaire about quality of life and satisfaction OTHER

Lupus erythematosus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de Dijon

Dijon, 21079, France

Location

Related Publications (2)

• Corneloup M, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Berthier S, Arnaud L, Bourredjem A, Amoura Z, Devilliers H; EQUAL Study Group. Disease-specific quality of life following a flare in systemic lupus erythematosus: an item response theory analysis of the French EQUAL cohort. Rheumatology (Oxford). 2020 Jun 1;59(6):1398-1406. doi: 10.1093/rheumatology/kez451.

  PMID: 31620787 RESULT

• Thibault T, Bourredjem A, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Audia S, Arnaud L, Amoura Z, Devilliers H; EQUAL Study Group. The mediating effect of fatigue in impaired quality of life in systemic lupus erythematosus: mediation analysis of the French EQUAL cohort. Rheumatology (Oxford). 2023 Sep 1;62(9):3051-3058. doi: 10.1093/rheumatology/kead020.

  PMID: 36655762 DERIVED

Study Officials

• Jean-François BESANCENOT

  CHU Dijon - Department of Internal Medicine and Systemic Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 22, 2013
• Study Start: December 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)