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Auto-immune Diseases and Quality of Life

NCT ID: NCT02855840

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-02

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Systemic Auto-immune Diseases Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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systemic lupus erythematous

completion of the quality of life questionnaire

Intervention Type OTHER

systemic sclerosis

completion of the quality of life questionnaire

Intervention Type OTHER

inflammatory myopathy

completion of the quality of life questionnaire

Intervention Type OTHER

Interventions

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completion of the quality of life questionnaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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DEVILLIERS FMR 2014

Identifier Type: -

Identifier Source: org_study_id