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

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Other: therapeutic education

• Registration Number: NCT02364908
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Primary Completion: 2016-11-30
• Study Completion: 2016-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Systemic Lupus	therapeutic education	-

Primary Outcome Measures

Name	Time	Method
measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.	baseline, at 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (7)

CH Dunkerque; 🇫🇷 Dunkerque, France

CH Douai; 🇫🇷 Douai, France

CH Hôpital Duchenne; 🇫🇷 Boulogne sur Mer, France

CH du Dr Schaffner; 🇫🇷 Lens, France

CHRU, Hôpital Huriez; 🇫🇷 Lille, France

Victor Provo Hospital; 🇫🇷 Roubaix, France

Valenciennes hospital; 🇫🇷 Valenciennes, France