NCT02364908已完成不适用
Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education
University Hospital, Lille7 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2014年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 7
- 主要终点
- measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •patients who refuse to sign the informed consent
- •patients who are under guardianship
研究组 & 干预措施
Patients with Systemic Lupus
Other
干预措施: therapeutic education (Other)
结局指标
主要结局
measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.
时间窗: baseline, at 12 months
次要结局
- number of non- adherent patients(at 12 months)
- hydroxychloroquinémie(between 6 months at 12 months)
- quality of life scale Coping(baseline, at 12 months)
研究者
研究点 (7)
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