Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment in Rio de Janeiro: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Medication adherence
研究概览
简要总结
This project aims to improve adherence rate through pharmaceutical care in patients with systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to improve the quality of life of these patients.
详细描述
Adherence to treatment is a primary determinant for the effectiveness of health care. Non-compliance may lead to therapeutic failure, make more difficult and complex the management of chronic diseases or cause death. The effectiveness of interventions on adherence has an important impact in the health of the population. Systemic lupus erythematosus (SLE) is an autoimmune disease with high proportion of hospital admissions and deaths and high cost of treatment. The prevalence of adherence in this group of patients in Brazil is very low (31.7%) and the drug treatment is complex. Our aim is to assess the effectiveness of Pharmaceutical Care in the adherence of drug treatment by SLE patients attended in a Rheumatology outpatient clinic in Rio de Janeiro, Brazil.
Randomized clinical trial (pragmatic trial), in which 120 adult patients with confirmed SLE diagnosis will be followed for 12 months, and randomized in two groups: the intervention group (attended by a pharmacist according to the Dader Method for Pharmaceutical Care), and the control group (attended by a non-pharmacist professional with counseling on hygiene/nutrition and reduction of risks in lupus therapy). The main outcome will be adherence to drug therapy and secondary outcomes the improvement of the medical condition and the quality of life of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •SLE diagnosis according to the 2012 SLICC (Systemic Lupus International Collaborating Clinics Group) SLE classification criteria.
- •Treatment with corticosteroids and antimalarials.
- •History of biopsy-proven lupus nephritis classes III, IV, or V (2003 International Society of Nephrology / Renal Pathology Society) or nephritic/nephrotic lupus flare not undergone to kidney biopsy.
排除标准
- •Current renal replacement therapy.
- •Renal transplantation.
- •Ongoing pulse therapy with cyclophosphamide and/or methylprednisolone.
- •Aid by caregiver.
- •Any psychiatric illness.
- •Inability to understand the questions of the questionnaire.
- •Patients'unwillingness to sign the informed consent.
结局指标
主要结局
Medication adherence
时间窗: 12 months
Medication adherence will be measured by use of the eight-item Morisk Medication Adherence Scale (MMAS) translated and validated to brazilian portuguese
次要结局
- SLE disease activity(12 months)
- Quality of life(12 months)