Community-Based Rehabilitation for Persons with Severe Mental Illness in a Rural Community of Karnataka: Methodology of a Randomized Controlled Study.
Community-Based Rehabilitation for Persons with Severe Mental Illness in a Rural Community of Karnataka: Methodology of a Randomized Controlled Study.
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DOI：
10.1177/0253717620971203
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发表时间：
2020-12
影响因子：
2.8
通讯作者：
Basavarajappa C
中科院分区：
文献类型：
--
作者：
Sivakumar T;Thirthalli J;Kumar CN;Basavarajappa C
工作转移已被建议作为一项战略，以接触精神病患者和弥合治疗差距。有必要探索任务转移使用现有的卫生工作人员，如认可的社会卫生活动家（ASHA）。在过去5年中，在Davanagere区（印度卡纳塔克邦）的Jagagalu Taluk（一个行政区），ASHA参与了正在进行的以社区为基础的康复（CBR）方案，该方案是通过公私伙伴关系实施的。本文旨在总结一项随机对照试验（RCT），以检查ASHA提供的CBR是否比常规治疗（TAU）对照组在减少与严重精神疾病（SMI）相关的残疾方面更有效。一组积极主动的ASHA已经在与我们合作，对患有SMI的人进行随访。对于本研究，我们将通过计算机生成的随机化列表以1：1的比例随机分配目前未被ASHA主动覆盖的区域，以接收ASHA交付的CBR组或TAU对照组。每组约100例的样本量足以确定干预组和对照组之间总IDEAS评分的效应量为0.5，功效为90%，α为0.05。我们使用SPIRIT（标准方案项目：介入试验建议）声明来描述试验方法。本研究已获得研究所伦理委员会的批准，并在CTRI注册（CTRI/2019/08/020585，日期：2019年8月6日）。受试者招募工作正在进行。患者将随访1年并进行评估。该试验由印度政府印度医学研究理事会资助。从公共卫生的角度来看，这项研究的结果将有助于通过ASHA为SMI患者提供具有成本效益和可复制的CBR。如果该模式取得成功，则可以在整个州/国家推广。这将大大有助于弥合巨大的治疗差距。
Task shifting has been recommended as a strategy to reach out to persons with mental illness and bridge the treatment gap. There is a need to explore task-shifting using existing health staff like Accredited Social Health Activists (ASHAs). ASHAs are involved in ongoing community-based rehabilitation (CBR) program run with a public–private partnership over the last 5 years at Jagaluru Taluk (an administrative block) in Davanagere district (Karnataka, India). This article aims to summarize a randomized controlled trial (RCT) to examine whether CBR delivered by ASHAs is more effective than treatment as usual (TAU) control group in reducing disability associated with severe mental illness (SMI). A group of proactive ASHAs is already working with us for a follow-up of persons with SMI. For the study, we would allocate areas that are currently not being covered proactively by ASHAs randomly in a 1:1 ratio via computer-generated randomization list to receive either ASHAs delivered CBR arm or TAU control group. A sample size of about 100 in each arm is enough to identify an effect size of 0.5 in total IDEAS score between the intervention and control arms with a power of 90% and an alpha of 0.05. We use the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement to describe the methods of the trial. The study has been approved by the institute ethics committee and registered with CTRI (CTRI/2019/08/020585 dated 6th August 2019). The recruitment of subjects is ongoing. The patients will be followed up for 1 year and assessed. The trial is funded by the Indian Council of Medical Research, Government of India. The results of the study will be helpful from a public health perspective in delivering cost-effective and replicable CBR for persons with SMI through ASHAs. If the model turns successful, this could be expanded throughout the state/country. This would go a long way in bridging the huge treatment gap.
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