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

两种速度处理模式预防老年人认知衰退的随机对照试验

• 批准号: 7937940
• 负责人: Fredric D Wolinsky
• 金额: $ 49.72万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7937940
• 关键词: Activities of Daily Living; Address; Adherence; Adult; Age; Age-associated memory impairment; Aging-Related Process; Area; Attention; Behavioral; Charge; Cognitive; Color; Community Medicine; Computer software; Computers; Control Groups; Control Locus; Demography; Digit structure; Dimensions; Disease Progression; Dose; Educational Intervention; Educational workshop; Elderly; Endogenous depression; Epidemiology; Funding; Future; Goals; Grant; Group Processes; Health; Home environment; Hour; Impaired cognition; Individual; Intervention; Linear Regressions; Logistic Regressions; Maintenance; Measures; Medical; Medical Care Costs; Memory; Modality; Modeling; Morbidity - disease rate; National Institute on Aging; Oral; Outcome; Outcome Measure; Participant; Personal Computers; Persons; Placebo Effect; Population; Prevention; Public Health; Publishing; Quality of life; Randomized; Randomized Controlled Trials; Relative (related person); Research; Risk; Risk Factors; Self Efficacy; Site; Stress; Supervision; Testing; Time; Trail Making Test; Training; Translating; United States National Academy of Sciences; United States National Institutes of Health; Vision; Word Association Tests; age group; aged; arm; base; clinically significant; cognitive function; cognitive training; comparative effectiveness; computerized; cost; depressive symptoms; disability; effectiveness research; follow-up; health care service utilization; health economics; health related quality of life; improved; instrument; mortality; prevent; primary outcome; processing speed; programs; psychosocial; public health relevance; response; secondary outcome; social; theories; vigilance

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, [e-mail]. 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.

描述（由申请人提供）：本申请解决了广泛的挑战区域05，比较有效性研究，特定挑战主题AG-102，预防和降低残疾风险因素的策略。 NIA联系人是Georgeanne Patmios女士，301-496-3138，[e-mail]。挑战主题05-AG-102要求进行随机对照试验（RCT）评估竞争干预措施或干预交付方式的比较有效性。 05-AG-102的主要目标是预防认知障碍，这会导致健康结果，包括改善生活质量，降低死亡率，发病率和疾病进展，减少医疗服务成本以及所选社会和行为维度的改善。有史以来最大，最严格的RCT涉及长期随访，是针对独立和重要老年人（活跃）研究的高级认知培训。尽管所有三种主动的认知训练干预措施（记忆，推理和处理速度）均有效提高其目标能力，但处理速度的速度取得了最大的收益，其中87％的参与者表现出可靠的改善。我们还显示了Active的处理速度的临床显着影响（但对记忆或推理干预措施没有影响）对各种健康结果，包括：（1）在预测的医疗费用中降低3％（P = .012） ; （2）与健康相关的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）可疑临床抑郁症发作的风险降低了38％（p <.01）； （5）改善自我评估健康，这转化为五年死亡率的绝对降低0.8％，相对死亡率降低10％（p <.05）； （6）内部控制源的有意义改善的可能性增加了64％（p <.05）。尽管处理速度的速度对这些影响的幅度，多样性和耐力，但仍需要进一步研究，在有三个原因的情况下进行广泛传播。首先，主动依赖于无接触对照组而不是注意力控制组，从而提高了安慰剂效应的潜力。其次，尽管助推器培训是向60％的活跃参与者提供的，但有条件以完成10个基线训练中的8个，使助推器效应和依从性效应相混淆。第三，现在可以使用一个新的，增值的处理速度软件，几乎可以在任何家用计算机上使用，因此可以大大降低交货成本并促进个人剂量和持续的助推器维护，但没有公开的证据增值版本与原始版本一样有效。因此，我们的具体目的是使用RCT和一年的后续行动来克服这些限制，这可以在NIH挑战赠款两年内完全完成。我们将将900名50岁或以上的900名参与者随机分为三组。 G1组（n = 400）将在10个现场会话中接受加工干预的增值速度，如有Active，将进一步的随机分配到一半（G1a）未接受增强助推器会议和一半（G1B）接受Onsite Booster sessions的一半（G1B）在11 - 月。 G2组（n = 250）将是注意力控制组，并将使用计算机化的跨字拼图程序进行10个现场会议。 G3组（n = 250）将显示如何在现场操作加工软件的增值速度，然后将其送回家以尽可能多地使用自己的个人计算机。我们的主要结果度量是处理速度，我们将使用几种可靠且有效的工具来提供多维评估，包括有用的视野测试，符号数字模式测试，步道制作测试，受控的口头单词关联测试，数字警惕性测试以及Stroop的颜色和单词测试。我们有七个针对这些主要结果度量的假设，这些假设将使用剩余的变更评分进行多个线性回归模型，用于连续结果，多个二进制（阈值变化）结果的逻辑回归模型以及poisson或负二项式回归模型的计数测量。我们还将评估对几种次要结果的影响，包括HRQOL，医疗保健利用，抑郁症状，功能能力，感知的压力，自我效能感和控制感。最后，我们将对50-64岁年龄的参与者进行分层分析，并在65岁以上的年龄段分别进行分别分析，以确定加工速度的效果大小是否按年龄组变化。 公共治疗性相关性：尽管一定程度的逐渐认知下降几乎是普遍的，并且是衰老过程的正常部分，但我们小组的先前研究表明，与年龄相关的认知能力下降可以接受干预。在处理速度的基础上，我们建议通过使用新开发的，增值的版本的速度来扩展和扩展从NIH资助的多站点高级认知培训，用于独立和重要的老年人（活跃）研究。处理软件几乎可以在没有监督的情况下用于任何家用计算机。当显示至少与原始版本一样有效时，加工速度的增值版本将准备好在50岁或以上的成年人中广泛实施，以减少和/或防止由残疾驱动的风险与年龄有关的认知下降。