Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial
Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial
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DOI：
10.1186/1745-6215-12-12
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发表时间：
2011-01-13
期刊：
影响因子：
2.5
通讯作者：
Thornicroft, Graham
中科院分区：
文献类型：
--
作者：
Chatterjee, Sudipto;Leese, Morven;Thornicroft, Graham
背景：在低收入国家，精神分裂症患者的治疗差距很大，社区服务很少，这主要是由于专科精神卫生保健人力资源的短缺。社区康复(CBR)，包括非专业卫生工作者，已被证明是可行的，可接受的，比常规护理更有效的精神分裂症患者在观察性研究中。这项研究的目的是评估非专业卫生工作者领导的、基于社区的协作护理(CCBC)干预与基于普通设施的护理(FBC)相结合，是否在改善印度精神分裂症患者及其照顾者的预后方面优于单独的FBC。方法/设计：这是一项在印度进行的多地点、平行组随机对照试验设计。这项试验将同时在印度的三个地点进行，精神分裂症患者将在提供知情同意后接受资格筛查和招募。试验参与者将被随机分配到CCBC+FBC和FBC ARM，比例分别为2：1，分配顺序是通过使用置换块预先准备的，并在站点内分层。有组织的CCBC干预将由训练有素的非专业社区卫生工作者(CHW)与治疗精神病学家合作提供。我们的目标是招募282名精神分裂症患者。主要结果是12个月后精神分裂症症状和残疾的严重程度降低。这项研究将按照良好的道德实践、数据分析和报告指南进行。讨论：如果一线社区卫生工作者提供的额外CCBC干预被证明与通常提供的护理相比是有效和经济的，这种干预可以扩大覆盖范围，并改善低收入国家精神分裂症患者和他们的照顾者的预后。
Background: There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR), involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC) intervention, combined with usual Facility Based Care (FBC), is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India.Methods/Design: This trial is a multi-site, parallel group randomised controlled trial design in India. The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2: 1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs) working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines.Discussion: If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries.