Strategy-based cognitive intervention for Parkinson disease: A pilot randomizedcontrolled trial

项目总结/摘要 这项工作的长期目标是减少残疾人与帕金森病（PD），使 他们可以科普认知能力下降，这样他们就可以执行和参与所需的活动和角色。PD是 第二大流行的神经退行性疾病，影响超过100万美国人， 随着人口老龄化，预计将增加相当大的个人和社会经济成本。认知 在患有PD的非痴呆患者中，损伤产生显著的残疾和降低的生活质量。 不幸的是，现有的PD医学（即手术和药理学）治疗不能预防、治疗或预防PD。 减轻认知障碍的负面功能后果。因此，开发新的， 有效的PD认知康复治疗是最优先的研究。调查人员已经开发出 一种新颖的、个性化的策略训练干预，以减轻认知能力下降，改善或维持 转移策略训练（Strategy Training for Transfer，STRAIT）它包括教人们使用有针对性的 日常生活中的补偿或适应策略，以应对或应对认知挑战， 实现功能目标。策略训练是脑损伤认知康复的实践标准， 中风，但其在PD中的应用是新颖的。此外，STRAIT还纳入了具体的循证培训 支持将战略使用及其益处转移到现实世界活动和环境的技术。这 在认知康复方法中，对日常功能概括的明确关注严重缺乏， 至今有PD的人目前的项目目标是测试和优化干预和研究 未来临床试验的程序，并最终转化为临床实践。研究设计为单一- 一项比较STRAIT与标准治疗对照（任务导向）的盲法初步随机对照试验（RCT） 认知训练）。该研究计划有三个具体目标：目标1将审查一般可行性（例如， 招募，保留），目标2将检查治疗保真度的受试者和治疗师相关方面， 目标3将生成STRAIT对日常功能影响的初步估计，以告知样本量 确定性RCT的计算。本研究的结果将直接告知RCT的R 01申请 以测试STRAIT的功效和/或有效性。它还将为调查人员提供关键数据， 经验和基础设施，以促进未来的效率，严谨性和临床试验的再现性， 在现实世界的临床实践中传播和实施。这项工作将满足迫切需要 对PD患者进行有效的认知干预，并最终对PD患者的功能和质量产生积极影响。 生活在这个人群中。

PROJECT SUMMARY/ABSTRACT The long term goal of this work is to reduce disability among people with Parkinson disease (PD) by enabling them to cope with cognitive decline so they can perform and participate in desired activities and roles. PD is the second most prevalent neurodegenerative disease, affecting over 1 million Americans and causing considerable personal and socioeconomic costs that are expected to rise as the population ages. Cognitive impairment produces significant disability and reduced quality of life among non-demented people with PD. Unfortunately, existing medical (i.e. surgical and pharmacological) treatments for PD do not prevent, treat, or mitigate the negative functional consequences of cognitive impairment. As such, the development of new, effective cognitive rehabilitation treatments for PD is a top research priority. The investigators have developed a novel, individualized, strategy training intervention to attenuate cognitive decline and improve or maintain daily function in PD (Strategy Training for Transfer, STRAIT). It involves teaching people to use targeted compensatory or adaptive strategies in everyday life to work around or through cognitive challenges and achieve functional goals. Strategy training is a practice standard for cognitive rehabilitation in brain injury and stroke, but its application in PD is novel. Furthermore, STRAIT incorporates specific evidence-based training techniques to support the transfer of strategy use and its benefits to real-world activities and contexts. This explicit focus on generalization to daily function is critically lacking in cognitive rehabilitation approaches for people with PD to-date. The current project objective is to test and optimize the intervention and study procedures for future clinical trials and eventual translation into clinical practice. The study design is a single- blind pilot randomized controlled trial (RCT) comparing STRAIT to a standard-of-care control (task-oriented cognitive training). The research plan has three specific aims: Aim 1 will examine general feasibility (e.g. recruitment, retention), Aim 2 will examine participant- and therapist-related aspects of treatment fidelity, and Aim 3 will generate preliminary estimates of STRAIT’s effect on daily function to inform sample size calculations for a definitive RCT. The results from this study will directly inform an R01 application for an RCT to test STRAIT’s efficacy and/or effectiveness. It will also provide the investigators with critical data, experience, and infrastructure to facilitate future efficiency, rigor, and reproducibility in clinical trials and dissemination and implementation in real-world clinical practice. This work will meet the pressing need for effective cognitive interventions for people with PD and will ultimately positively impact function and quality of life in this population.