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: 7807539
• 负责人: Fredric D Wolinsky
• 金额: $ 49.96万
• 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 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7807539
• 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; 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; Upper arm; Vision; Word Association Tests; age group; aged; 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、残疾预防和风险因素减少策略。 NIA 联系人为 Georgeanne Patmios 女士，电话：301-496-3138，邮箱：[e-mail]。挑战主题 05-AG-102 呼吁进行随机对照试验 (RCT) 来评估竞争干预措施或干预实施模式的比较有效性。 05-AG-102 的主要目标是预防认知障碍，从而带来健康结果，包括提高生活质量、降低死亡率、发病率和疾病进展、降低医疗费用以及改善特定的社会和行为维度。迄今为止规模最大、最严格、涉及长期随访的随机对照试验是针对独立和重要老年人的高级认知训练（ACTIVE）研究。尽管所有三种主动认知训练干预措施（记忆、推理和处理速度）都能有效提高他们的目标能力，但处理速度组的收益最大，87% 的参与者表现出可靠的改善。我们还显示了 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着影响，包括：(1) 预计医疗费用减少 3% (p = .012)； (2) 全球健康相关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 30% (p = .012)； (4) 疑似临床抑郁症的发病风险降低 38% (p < .01)； (5) 自评健康状况的改善，意味着五年死亡率绝对下降 0.8%，相对死亡率下降 10% (p < .05)； (6) 内部控制源有意义改善的可能性增加 64% (p < .05)。尽管处理干预速度的这些影响具有规模、多样性和持久性，但由于三个原因，在保证广泛传播之前还需要进一步研究。首先，ACTIVE 依赖于非接触对照组而不是注意力对照组，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 ACTIVE 参与者，但其条件是完成 10 次基线训练课程中的 8 次以上，从而混淆了强化效果与坚持效果。第三，现在有一种新的增值版本的处理速度软件，几乎可以在任何家用计算机上使用，因此可以大大降低交付成本，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，我们的具体目标是使用随机对照试验（RCT）和一年的随访来克服这些限制，该随机对照试验可以在 NIH 挑战拨款的两年期内完全完成。我们将 900 名 50 岁或以上的参与者随机分为三组。 G1 组 (N=400) 将在 10 次现场治疗中获得处理干预的增值速度，与 ACTIVE 中一样，并进一步随机化为一半 (G1a) 不接受加强治疗，另一半 (G1b) 在 11 个月时接受现场加强治疗。 G2 组（N=250）将是注意力控制组，将接受 10 次使用计算机填字游戏程序的现场会议。 G3组（N=250）将在现场展示如何操作增值速度的处理软件，然后被送回家在自己的个人电脑上随意使用。我们的主要结果衡量标准是处理速度，我们将使用几种可靠且有效的工具来提供多维评估，包括有用视野测试、符号数字模态测试、轨迹制作测试、受控口语单词关联测试、数字警惕性测试以及斯特鲁普颜色和单词测试。我们对这些主要结果指标有七个假设，将使用针对连续结果的残差变化评分多重线性回归模型、针对二元（阈值变化）结果的多重逻辑回归模型以及针对计数指标的泊松或负二项式回归模型进行测试。我们还将评估对几个次要结果的影响，包括 HRQoL、医疗保健利用率、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50-64岁的参与者进行分层分析，并分别对65岁或以上的参与者进行分层分析，以确定处理干预速度的效应大小是否因年龄组而异。 公共健康相关性：虽然某种程度的逐渐认知能力下降几乎是普遍现象，并且是衰老过程的正常部分，但我们小组之前的研究表明，与年龄相关的认知能力下降是可以干预的。基于处理速度理论，我们建议通过使用新开发的处理速度软件的增值版本来扩展和扩展 NIH 资助的多站点独立和重要老年人高级认知训练 (ACTIVE) 研究的结果，该软件几乎可以在没有监督的情况下在任何家用计算机上使用。当证明至少与原始版本一样有效时，处理软件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/或预防因年龄相关的认知能力下降而导致的残疾风险。