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

Study Overview
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Brief Summary
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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).

Official Title
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Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Other: therapeutic education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Systemic Lupus<br> | Other: therapeutic education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment. |  | baseline, at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hydroxychloroquinémie | Monitoring of blood levels of hydroxychloroquinémie | between 6 months at 12 months | 
| number of non- adherent patients | Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ; | at 12 months | 
| quality of life scale Coping | scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item | baseline, at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antimalarials, therapeutic education, Coping questionnaire, systemic lupus erythematosus, MASRI questionnaire, morisky medication adherence scale, lupus Quality Of Life, internal medicine