Auto-immune Diseases and Quality of Life

Quality of Life Clinical Trial

— QUALIMAIRAU  

Official title:

Qualitative Study of the Consequences of Auto-immune Diseases on Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855840
• Other study ID #: DEVILLIERS FMR 2014
• Status: Completed
• Phase: N/A
• First received: July 28, 2016
• Last updated: October 9, 2017
• Start date: March 2, 2015
• Est. completion date: March 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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... ?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Immune System Diseases
• Quality of Life
• Systemic Auto-immune Diseases

Intervention

Other:
• completion of the quality of life questionnaire

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	semi-directive individual interviews in the 3 groups of patients		day one