Auto-immune Diseases and Quality of Life

Completed

• Conditions: Systemic Auto-immune Diseases; Quality of Life
• Interventions: Other: completion of the quality of life questionnaire

• Registration Number: NCT02855840
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM) are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for 100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases and require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM on the everyday life of patients are heavy, and notably linked to skin involvement, to diminished functional capacities and psychological problems. The vast majority of these diseases concern middle-aged, professionally-active individuals, for whom the socio-professional repercussions are major and too often neglected. The aim of this study is to analyse the consequences of auto-immune diseases on quality of life. Current quality of life questionnaires are not suitable, and do not reveal the reality of the situation and its different nuances. In this research, the quality of life of patients will be envisaged through their everyday lives. How do these patients construct the social reality of the disease? How do they perceive their health status and their social situation? How do they organize their everyday lives around the disease: work, leisure, relationships with their entourage... ?

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-02
• Primary Completion: 2016-03
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-04
• Study Completion: 2017-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• For all patients:
• Patients aged 18 to 75 years
• Patients able to understand written and spoken French
• Patients who have been given oral and written information about the research

For patients with SLE:

• SLE defined by American College of Rheumatology (ACR) 1997 criteria

For patients with systemic sclerosis:

• SSc according to the Leroy or American Rheumatism Association (ARA) criteria

For patients with IM:

• IM according to the Trojanov criteria

Exclusion Criteria

• Refusal to take part in the study
• Cognitive/psychological status incompatible with interviews

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
systemic lupus erythematous	completion of the quality of life questionnaire	-
systemic sclerosis	completion of the quality of life questionnaire	-
inflammatory myopathy	completion of the quality of life questionnaire	-

Primary Outcome Measures

Name	Time	Method
semi-directive individual interviews in the 3 groups of patients	day one

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France