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Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus

NCT ID: NCT01904812

Last Updated: 2018-12-27

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

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-05-31

Brief Summary

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Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.

Detailed Description

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Conditions

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Lupus Erythematosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Lupus erythematosus

Group Type OTHER

Questionnaire about quality of life and satisfaction

Intervention Type OTHER

Interventions

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Questionnaire about quality of life and satisfaction

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \- Patients meeting ACR 1997 classification criteria for systemic lupus erythematosus.
* Patients able to understand written and spoken French.
* Patients aged from 18 to 75 years
* Patients who have received written and oral information about the research.

Exclusion Criteria

* \- Patients aged less than 18 years
* Patients aged more than 75 years
* Severe mental retardation Any impairment of abilities to understand that make self-evaluation impossible
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

Principal Investigators

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Jean-François BESANCENOT

Role: PRINCIPAL_INVESTIGATOR

CHU Dijon - Department of Internal Medicine and Systemic Diseases

Locations

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CHU de Dijon

Dijon, , France

Site Status

Countries

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France

References

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Thibault T, Bourredjem A, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Audia S, Arnaud L, Amoura Z, Devilliers H; EQUAL Study Group. The mediating effect of fatigue in impaired quality of life in systemic lupus erythematosus: mediation analysis of the French EQUAL cohort. Rheumatology (Oxford). 2023 Sep 1;62(9):3051-3058. doi: 10.1093/rheumatology/kead020.

Reference Type DERIVED
PMID: 36655762 (View on PubMed)

Corneloup M, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Berthier S, Arnaud L, Bourredjem A, Amoura Z, Devilliers H; EQUAL Study Group. Disease-specific quality of life following a flare in systemic lupus erythematosus: an item response theory analysis of the French EQUAL cohort. Rheumatology (Oxford). 2020 Jun 1;59(6):1398-1406. doi: 10.1093/rheumatology/kez451.

Reference Type DERIVED
PMID: 31620787 (View on PubMed)

Other Identifiers

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Besancenot PHRC N 2010

Identifier Type: -

Identifier Source: org_study_id