Lupus and Observance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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
排除标准
- •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
结局指标
主要结局
The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)
时间窗: 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.
次要结局
- Patients considered as observing and non-observing will be compared according to the activity of the disease(40 days)
- Patients considered as observing and non-observing will be compared according to number of prescribed medication(40 days)
- Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders(40 days)