RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults

描述(由申请人提供)：本申请涉及广泛的挑战领域05，比较有效性研究，具体挑战主题AG-102，残疾预防和减少风险因素战略。NIA的联系人是Georgeanne Patmios女士，电话：301-496-3138，电子邮件：patmiosg@nia.nih.gov。挑战主题05-AG-102要求进行随机对照试验(RCT)，以评估相互竞争的干预措施或干预提供方式的相对有效性。05-AG-102的主要目标是预防认知障碍，从而导致健康结果，包括提高生活质量，降低死亡率、发病率和疾病进展，降低医疗费用，以及在选定的社会和行为方面有所改善。有史以来进行的规模最大、最严格的长期跟踪研究是独立和有活力的老年人高级认知培训(积极)研究。虽然三种积极的认知训练干预(记忆、推理和加工速度)都有效地提高了他们的目标能力，但加工组的速度进步最大，87%的参与者表现出可靠的进步。我们还展示了Active的处理干预速度(但对记忆或推理干预没有影响)对各种健康结果的临床显著影响，包括：(1)预测的医疗费用减少了3%(p=.012)；(2)与健康相关的全球生活质量下降的风险降低了38%(HRQOL；p=.004)；(3)抑郁症状恶化的风险降低了30%(p=.012)；(4)疑似临床抑郁发作的风险降低了38%(p&lt；(5)自我评估健康状况的改善，这意味着五年死亡率绝对降低0.8%，相对死亡率降低10%(p&lt；.05)；以及(6)内部控制点有意义改善的可能性(p&lt；.05)增加了%。尽管处理干预的速度的这些影响的规模、多样性和持久性，但由于三个原因，在广泛传播之前还需要进一步研究。首先，Active依赖于非接触性控制组，而不是注意力控制组，这增加了安慰剂效应的可能性。其次，虽然强化训练是随机提供给60%的积极参与者，但它是在完成10个基线训练课程中的8个的条件下提供的，混淆了强化效果和坚持效果。第三，现在有了一个新的增值版本的处理速度软件，可以在几乎任何家庭计算机上使用，因此可以极大地降低递送成本，方便个人剂量和正在进行的助推器维护，但没有公布的证据表明，增值版本与原始版本一样有效。因此，我们的具体目标是通过一项为期一年的RCT来克服这些限制，该跟踪可以在NIH挑战补助金的两年期限内完全完成。我们将把900名年龄在50岁或以上的参与者随机分为三组。G1组(N=400)将在10个活动的现场会话中获得处理干预的增值速度，并进一步随机到不接受强化治疗的一半(G1a)和11个月后接受现场强化治疗的一半(G1b)。G2组(N=250)将作为注意控制组，并将接受10次现场培训，使用计算机纵横字谜程序。G3组(N=250)将被展示如何在现场操作处理软件的增值速度，然后将被送回家，在他们自己的个人计算机上随时使用。我们的主要测量结果是加工速度，我们将使用几种可靠和有效的工具来提供多维评估，包括有用视野测试、符号数字通道测试、连线测试、受控口语单词联想测试、数字警觉性测试和Stroop颜色和单词测试。我们对这些主要结果指标有七个假设，将使用残差变化分数多元线性回归模型检验连续结果，多元Logistic回归模型检验二元(阈值变化)结果，泊松或负二项回归模型检验计数指标。我们还将评估对几个次要结果的影响，包括HRQL、医疗保健利用、抑郁症状、功能能力、感知压力、自我效能和控制感。最后，我们将对50-岁的被试进行分层分析，并分别在65岁及以上的被试中进行分层分析，以确定加工干预速度的影响大小是否因年龄组而异。 与公共健康相关：尽管某种程度的认知能力逐渐下降几乎是普遍的，也是衰老过程中正常的一部分，但我们团队之前的研究表明，与年龄相关的认知能力下降是可以干预的。在处理速度理论的基础上，我们建议通过使用新开发的增值版本的处理速度软件来扩展和扩展NIH资助的多站点独立和重要老年人高级认知培训(Active)研究的结果，该软件可以在没有监督的情况下在几乎任何家庭计算机上使用。当被证明至少与原始软件一样有效时，增值版本的处理速度软件将准备好在50岁或50岁以上的成年人中广泛实施，以减少和/或防止因年龄相关的认知能力下降而导致的残疾风险。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area 05, Comparative Effectiveness Research, specific Challenge Topic AG-102, Prevention and Risk Factor Reduction Strategies for Disabilities. The NIA contact is Ms. Georgeanne Patmios, 301-496-3138, patmiosg@nia.nih.gov. Challenge Topic 05-AG-102 calls for randomized controlled trials (RCTs) to evaluate the comparative effectiveness of competing interventions or modes of intervention delivery. A prime target for 05-AG-102 is the prevention of cognitive disability that results in health outcomes including improved quality of life, decreased mortality, morbidity, and disease progression, reduced medical care costs, and improvements in selected social and behavioral dimensions. The largest and most rigorous RCT ever conducted involving long-term follow-up was the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study. Although all three ACTIVE cognitive training interventions (memory, reasoning, and speed of processing) were effective at improving their targeted abilities, the speed of processing group had the largest gains, with 87% of participants showing reliable improvement. We have also shown clinically significant effects of ACTIVE's speed of processing intervention (but no effects for the memory or reasoning interventions) on a variety of health outcomes, including: (1) a 3% reduction (p = .012) in predicted medical expenses; (2) a 38% reduction in the risk of global decline in health-related quality of life (HRQoL; p = .004); (3) a 30% reduction in the risk of worsening depressive symptoms (p = .012); (4) a 38% reduction in the risk of the onset of suspected clinical depression (p < .01); (5) improvements in self-rated health that translate to a 0.8% absolute reduction in the five-year mortality rate and a 10% relative mortality reduction (p < .05); and, (6) a 64% greater likelihood (p < .05) of meaningful improvements in internal locus of control. Despite the magnitude, diversity, and endurance of these effects of the speed of processing intervention, further research is needed before widespread dissemination is warranted for three reasons. First, ACTIVE relied on a no-contact control group rather than an attention control group, raising the potential for placebo effects. Second, although booster training was randomly offered to 60% of ACTIVE participants, it was offered conditional on completing > 8 of the 10 baseline training sessions, confounding booster effects with adherence effects. Third, a new, value-added version of the speed of processing software is now available that can be used on almost any home computer, and could thus dramatically reduce delivery costs and facilitate individual dosing and ongoing booster maintenance, but there is no published evidence that the value-added version is as effective as the original. Therefore, our specific aims are to overcome these limitations using an RCT with one-year follow- up that can be fully completed within the NIH Challenge Grant two-year period. We will randomize 900 participants aged 50 years old or older to three groups. Group G1 (N=400) will receive the value-added speed of processing intervention in 10 onsite sessions as in ACTIVE, with further randomization to one half (G1a) not receiving booster sessions and one half (G1b) receiving onsite booster sessions at 11-months. Group G2 (N=250) will be the attention control group and will receive 10 onsite sessions using a computerized cross-word puzzle program. Group G3 (N=250) will be shown how to operate the value- added speed of processing software on site, and will then be sent home to use it as often as they wish on their own personal computer. Our primary outcome measure is speed of processing, and we will use several reliable and valid instruments to provide a multidimensional assessment, including the Useful Field of View Test, the Symbol Digit Modalities Test, the Trail Making Test, the Controlled Oral Word Association Test, the Digit Vigilance Test, and the Stroop Color and Word Test. We have seven hypotheses for these primary outcome measures which will be tested using residualized change score multiple linear regression models for continuous outcomes, multiple logistic regression models for binary (threshold change) outcomes, and Poisson or negative binomial regression models for count measures. We will also evaluate the effects on several secondary outcomes, including HRQoL, healthcare utilization, depressive symptoms, functional abilities, perceived stress, self-efficacy, and sense of control. Finally, we will conduct stratified analysis among participants aged 50-64 years old, and separately among those aged 65 years or older in order to determine whether the effect size of the speed of processing intervention varies by age group. PUBLIC HEALH RELEVANCE: Although some degree of gradual cognitive decline is nearly universal and a normal part of the aging process, previous research by our group has shown that age-related cognitive decline is amenable to intervention. Building on speed of processing theory, we propose to extend and expand the findings from the NIH-funded, multi-site Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study by using a newly developed, value-added version of the speed of processing software that can be used on virtually any home computer without supervision. When shown to be at least as efficacious as the original, the value-added version of the speed of processing software will then be ready for widespread implementation among adults aged 50 years old or older to reduce and/or prevent the risk of disability driven by age-related cognitive decline.