Lupus and Observance (LUPOBS)
A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis.
New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential.
Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study.
The study primary objective is to determine risk factors for non-observance
The secondary objectives are to:
- Measure the observance rate of patients with systemic lupus in Martinique.
- Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Martinique
-
Fort-de-France、Martinique、法国、97200
- CHU de Martinique
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age ≥ 18 years
- Systemic lupus defined according to the diagnostic criteria of the American College of Rheumatology " 1997, diagnosed for at least 6 months; Or Skin Lupus
- Consultation or hospitalization at the University Hospital of Martinique, in either services of Internal Medicine, Rheumatology or Dermatology.
- Prescription of hydroxychloroquine (Plaquenil®) for at least 6 months
- Affiliate or beneficiary of a social security scheme.
- Patient not opposed to participate in the study
Exclusion Criteria:
- Age <18 years or patient under guardianship
- Patient not speaking and / or not understanding French
- No prescription and/or contraindication to hydroxychloroquine
- Systemic lupus outbreak with neurological impairment defined by SLEDAI score by a psychosis (disruption of normal activity in relation to a severe alteration of the perception of reality. Includes: hallucinations, incoherence, impoverishment of the content of thought, illogical reasoning, bizarre behavior, disorganized or catatonic) or brain damage (with impairment of mental functions with impaired orientation, memory or other brutal appearance and fluctuating evolution).
- History of psychiatric disorders: personality disorders, psychoses, severe depression
- Hospitalization with a life-threatening clinical condition that does not allow to answer questions
- Non affiliated patient or beneficiary of a social security scheme.
- Patient refusing to participate in the study
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)
大体时间：Reflects the Plaquenil intake during the 40 previous days
|
The HCQ dosage is assayed on whole blood (6ml) by high-pressure liquid chromatography performance, reproducible and inexpensive method. Only one laboratory centralizes the sampling. A dosage below 200 ng/ml or 0.2 mg/l defines a non-observing patient within the 40 days above. |
Reflects the Plaquenil intake during the 40 previous days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patients considered as observing and non-observing will be compared according to the activity of the disease
大体时间：40 days
|
Activity of the disease : Systemic lupus considered as active for a SELENA-SLEDAI score ≥ 6
|
40 days
|
|
Patients considered as observing and non-observing will be compared according to number of prescribed medication
大体时间：40 days
|
40 days
|
|
|
Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders
大体时间：40 days
|
Presence of anxiety and/or depressive disorders, according to the Hospital Anxiety And Depression Scale (HAD), a score > to 10
|
40 days
|
合作者和调查者
调查人员
- 首席研究员：Katlyne POLOMAT, MD、CHU of Martinique
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 16/B/09
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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