Auto-immune Diseases and Quality of Life

NCT02855840 | Completed

• 1 other identifier: DEVILLIERS FMR 2014
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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... ?

Conditions

Systemic Auto-immune Diseases; Quality of Life

Outcome Measures

Primary Outcomes (1)

• semi-directive individual interviews in the 3 groups of patients

  day one

Study Arms (3)

systemic lupus erythematous

Other: completion of the quality of life questionnaire

systemic sclerosis

Other: completion of the quality of life questionnaire

inflammatory myopathy

Other: completion of the quality of life questionnaire

Interventions

completion of the quality of life questionnaire OTHER

inflammatory myopathy; systemic lupus erythematous; systemic sclerosis

Eligibility Criteria

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

Study Population

patients with Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 2, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 4, 2016
• Study Start: March 2, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-10

Locations

FR (1)