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Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus (EQUAL)

Primary Purpose

Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire about quality of life and satisfaction
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lupus Erythematosus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Dijon

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lupus erythematosus

Arm Description

Outcomes

Primary Outcome Measures

data for quality of life and satisfaction
Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20

Secondary Outcome Measures

Clinical data
Question about any recent hospitalization pregnancy contraception Compliance score of Girerd Fatigue score MFI-20 tobacco consumption Score of CES-D depression Score stress response WCC

Full Information

First Posted
July 12, 2013
Last Updated
December 26, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01904812
Brief Title
Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus
Acronym
EQUAL
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lupus erythematosus
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Questionnaire about quality of life and satisfaction
Primary Outcome Measure Information:
Title
data for quality of life and satisfaction
Description
Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 months
Secondary Outcome Measure Information:
Title
Clinical data
Description
Question about any recent hospitalization pregnancy contraception Compliance score of Girerd Fatigue score MFI-20 tobacco consumption Score of CES-D depression Score stress response WCC
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François BESANCENOT
Organizational Affiliation
CHU Dijon - Department of Internal Medicine and Systemic Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31620787
Citation
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.
Results Reference
derived

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

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