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

October 12, 2018 updated by: University Hospital, Lille

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne sur Mer, France, 62321
        • CH Hôpital Duchenne
      • Douai, France, 59507
        • CH DOUAI
      • Dunkerque, France, 59385
        • Ch Dunkerque
      • Lens, France, 62307
        • CH du Dr Schaffner
      • Lille, France
        • CHRU, Hôpital Huriez
      • Roubaix, France, 59056
        • Victor Provo Hospital
      • Valenciennes, France, 59322
        • Valenciennes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hydroxychloroquinémie
Time Frame: between 6 months at 12 months
Monitoring of blood levels of hydroxychloroquinémie
between 6 months at 12 months
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 ;
at 12 months
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
baseline, at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Région Nord-Pas de Calais, France

Investigators

  • Study Chair: Eric Hachulla, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_65
  • 2014-A00735-42 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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