在患有与艾滋病相关神经认知障碍的成年患者中测试一种计算机化认知训练方案：随机对照试验的原理与方案
Testing a Computerized Cognitive Training Protocol in Adults Aging With HIV-Associated Neurocognitive Disorders: Randomized Controlled Trial Rationale and Protocol.
作者信息
Vance David, Fazeli Pariya, Shacka John, Nicholson William, McKie Peggy, Raper James, Azuero Andres, Wadley Virginia, Ball Karlene
机构信息
School of Nursing, University of Alabama at Birmingham, Birmingham, AL, United States.
Department of Pharmacology & Toxicology, University of Alabama at Birmingham, Birmingham, AL, United States.
出版信息
JMIR Res Protoc. 2017 Apr 26;6(4):e68. doi: 10.2196/resprot.6625.
BACKGROUND
HIV-associated neurocognitive disorders occur in nearly 50% of adults with HIV. Such disorders can interfere with everyday functioning such as driving and medication adherence. Therefore, cognitive interventions are needed to address such neurocognitive disorders as well as improve everyday functioning, especially as people age with HIV.
OBJECTIVE
This article reports and discusses the overall rationale and development of speed of processing training, a computerized Internet cognitive training program, to improve this specific neurocognitive ability as well as everyday functioning and quality of life in adults aging with HIV. Although this protocol has been shown to improve speed of processing, everyday functioning, and quality of life in healthy, community-dwelling older adults in the advanced cognitive training in vital elderly (ACTIVE) study, its efficacy in adults aging with HIV has not been established. Nevertheless, such a cognitive intervention is particularly germane as 52%-59% of adults with HIV experience HIV-associated neurocognitive disorders (HAND), and both the frequency and severity of such disorders may increase with advancing age.
METHODS
The description of this longitudinal randomized controlled trial covers the following: (1) rationale for speed of processing training in this clinical population, (2) overview of overall study design, (3) eligibility criteria and HAND, (4) intervention dosage, (5) assessment battery, and (6) examination of biomarkers.
RESULTS
The project was funded in April 2016 and enrolment is on-going. The first results are expected to be submitted for publication in 2020.
CONCLUSIONS
Similar novel cognitive intervention approaches are suggested as they may be of value to those with HAND and may utilize similar features of this current randomized controlled trial (RCT) protocol to examine their therapeutic efficacy.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02758093; https://clinicaltrials.gov/ct2/show/NCT02758093 (Archived by Webcite at http://www.webcitation.org/6p8C5fBCX).
背景
近50%的成年HIV感染者会出现与HIV相关的神经认知障碍。此类障碍会干扰日常功能，如驾驶和药物依从性。因此，需要认知干预来解决此类神经认知障碍，并改善日常功能，尤其是随着感染HIV的人群年龄增长。
目的
本文报告并讨论了处理速度训练（一种计算机化的互联网认知训练项目）的总体原理及开发情况，以提高感染HIV的成年人的这种特定神经认知能力以及日常功能和生活质量。尽管在“老年认知训练对老年人至关重要”（ACTIVE）研究中，该方案已被证明能提高健康社区老年人的处理速度、日常功能和生活质量，但其在感染HIV的成年人中的疗效尚未确定。然而，这种认知干预尤为相关，因为52% - 59%的成年HIV感染者会经历与HIV相关的神经认知障碍（HAND），且此类障碍的频率和严重程度可能会随着年龄增长而增加。
方法
这项纵向随机对照试验的描述涵盖以下内容：（1）该临床人群中处理速度训练的原理，（2）总体研究设计概述，（3）入选标准与HAND，（4）干预剂量，（5）评估组，以及（6）生物标志物检查。
结果
该项目于2016年4月获得资助，招募工作正在进行中。预计首批结果将于2020年提交发表。
结论
建议采用类似的新型认知干预方法，因为它们可能对HAND患者有价值，并且可能利用当前这项随机对照试验（RCT）方案的类似特征来检验其治疗效果。
试验注册
ClinicalTrials.gov NCT02758093；https://clinicaltrials.gov/ct2/show/NCT02758093（由Webcite存档于http://www.webcitation.org/6p8C5fBCX）
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