Rubio-Valera Maria, Serrano-Blanco Antoni, Travé Pere, Peñarrubia-María M Teresa, Ruiz Mar, Pujol Marian March
Sant Joan de Déu - Serveis de Salut Mental, Fundació Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, Spain.
BMC Public Health. 2009 Aug 5;9:284. doi: 10.1186/1471-2458-9-284.
Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression.
METHODS/DESIGN: A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75) diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain). Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9), anxiety (STAI-S), health-related quality of life (EuroQol-5D), satisfaction with the treatment received, side-effects, chronic physical conditions and socio-demographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI).
This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical intervention programme in the context of primary care.
NCT00794196.
抑郁症是最常见且成本高昂的精神障碍，其治疗方法有待改进。不遵循临床指南以及不坚持治疗会限制抑郁症药物治疗的疗效。通过药学服务，药剂师可以提高患者的依从性和健康水平。本研究的目的是评估为提高基层医疗中抑郁症患者的依从性和治疗效果而开展的社区药剂师干预措施的有效性和成本效益。
方法/设计：一项为期6个月随访的随机对照试验，比较在基层医疗中接受药学服务支持项目的患者与接受常规治疗的患者。总样本包括194名年龄在18至75岁之间、在西班牙巴塞罗那省一家基层医疗健康中心被诊断为抑郁症的患者。将要求受试者签署书面知情同意书以参与研究。将使用《精神障碍诊断与统计手册》第一版（SCID-I）确诊。干预措施包括一个教育项目，重点是提高对药物治疗的认识，让患者意识到依从性的重要性，减少耻辱感，使患者对副作用放心，并强调执行全科医生建议的重要性。将在基线时以及3个月和6个月后进行测量。主要结局指标是对抗抑郁药的依从性。次要结局指标包括：抑郁症的临床严重程度（患者健康问卷-9，PHQ-9）、焦虑（状态特质焦虑问卷-状态量表，STAI-S）、健康相关生活质量（欧洲五维度健康量表，EuroQol-5D）、对所接受治疗的满意度、副作用、慢性身体状况和社会人口统计学特征。将使用客户服务收据清单（CSRI）的改编版评估医疗保健和社会护理服务的使用情况。
本试验将为卫生专业人员和政策制定者提供有关基层医疗背景下药物干预项目的有效性和成本效益的宝贵信息。
NCT00794196。
