NCT02855840

Completed

Auto-immune Diseases and Quality of Life

Centre Hospitalier Universitaire Dijon Source

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Other study identifiers

Sponsor study identifier

DEVILLIERS FMR 2014

Study Type

observational

Actual enrollment (reported)

77

Locations

1 country

Sites

1

Timeline

Study Start

March 2, 2015

Actual (reported)

Primary Completion

March 2016

Actual (reported)

Study Completion

March 2017

Actual (reported)

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... ?

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 77 participants
Study completion date: March 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2, 2015
Actual (reported)
Primary Completion
March 2016
Actual (reported)
First Submitted
July 28, 2016
Actual (reported)
First Posted
August 4, 2016
Actual (reported)
Study Completion
March 2017
Actual (reported)

Last Updated: October 10, 2017
Status Verified: October 2017
Last Update Submitted: October 9, 2017

Conditions

Quality of Life Systemic Auto-immune Diseases

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 questionnaireOther

inflammatory myopathysystemic lupus erythematoussystemic sclerosis

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

For all patients:

Sponsors & Collaborators

Centre Hospitalier Universitaire Dijon
Otherlead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 2, France

Enrollment

77 participants (actual enrollment reported by the registry).

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

Actual (reported)

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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

Contact the study team to confirm eligibility.

Primary Completion

March 2016

Actual (reported)

Study Completion

March 2017

Actual (reported)

Last Updated

October 10, 2017

Record last verified: 2017-10

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT02855840
Data provider: ClinicalTrials.gov
Source updated: 2017-10-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:55 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

systemic lupus erythematous

systemic sclerosis

inflammatory myopathy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations