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Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus (ESSTIM)

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: NCT02364908
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Région Nord-Pas de Calais, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).

The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Other: therapeutic education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education
Actual Study Start Date : December 2014
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Patients with Systemic Lupus Other: therapeutic education
This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.




Primary Outcome Measures :
  1. measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment. [ Time Frame: baseline, at 12 months ]

Secondary Outcome Measures :
  1. hydroxychloroquinémie [ Time Frame: between 6 months at 12 months ]
    Monitoring of blood levels of hydroxychloroquinémie

  2. number of non- adherent patients [ Time Frame: at 12 months ]
    Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ;

  3. quality of life scale Coping [ Time Frame: baseline, at 12 months ]
    scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with a systemic lupus with ACR criteria (at least 4 criterias)
  • patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day.

Exclusion Criteria:

  • patients who refuse to sign the informed consent
  • patients who are under guardianship

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): NCT02364908


Locations
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France
CH Hôpital Duchenne
Boulogne sur Mer, France, 62321
CH Douai
Douai, France, 59507
CH Dunkerque
Dunkerque, France, 59385
CH du Dr Schaffner
Lens, France, 62307
CHRU, Hôpital Huriez
Lille, France
Victor Provo Hospital
Roubaix, France, 59056
Valenciennes hospital
Valenciennes, France, 59322
Sponsors and Collaborators
University Hospital, Lille
Région Nord-Pas de Calais, France
Investigators
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Study Chair: Eric Hachulla, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02364908     History of Changes
Other Study ID Numbers: 2013_65
2014-A00735-42 ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
systemic lupus erythematosus
antimalarials
therapeutic education
Coping questionnaire
MASRI questionnaire
morisky medication adherence scale
lupus Quality Of Life
internal medicine
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents