Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 67 of 215 for:    Inflammatory Myopathies

Auto-immune Diseases and Quality of Life (QUALIMAIRAU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02855840
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
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... ?

Condition or disease Intervention/treatment
Systemic Auto-immune Diseases Quality of Life Other: completion of the quality of life questionnaire

Layout table for study information
Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Qualitative Study of the Consequences of Auto-immune Diseases on Quality of Life
Actual Study Start Date : March 2, 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. semi-directive individual interviews in the 3 groups of patients [ Time Frame: day one ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855840


Locations
Layout table for location information
France
CHU Dijon Bourgogne
Dijon, France, 2
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02855840     History of Changes
Other Study ID Numbers: DEVILLIERS FMR 2014
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Immune System Diseases
Autoimmune Diseases