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Completed

NCT Number: NCT02364908

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

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).

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Hôpital Duchenne, Boulogne-sur-Mer, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic education

Other

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 outcomes

  1. measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.

    Time frame: baseline, at 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Région Nord-Pas de Calais, France

Registry information

Official study title

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

Acronym: ESSTIM

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2015
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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