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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02364908

Acronym

ESSTIM

Enrollment

158

Registered

2015-02-18

Start date

2014-12-31

Completion date

2016-12-31

Last updated

2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus, antimalarials, therapeutic education, Coping questionnaire, MASRI questionnaire, morisky medication adherence scale, lupus Quality Of Life, internal medicine

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).

Interventions

OTHERtherapeutic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
hydroxychloroquinémie	between 6 months at 12 months	Monitoring of blood levels of hydroxychloroquinémie
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 ;
quality of life scale Coping	baseline, at 12 months	scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026