ACTIVE Phase II: Coordinating Center

描述(申请人提供)：本申请是名为“老年人认知干预试验-CC”申请的续展。这个应用程序是针对协调中心的。Active(独立和充满活力的老年人的高级认知训练)第一阶段是一项随机对照试验，包括三个认知干预分支，旨在解决改善基本认知是否有助于维持老年人的功能独立的问题。根据《美国医学会杂志》(11/12/02)的报告，第一阶段发现了强大、广泛和持久的认知能力特异性训练效果。这些效应的大小与其他纵向研究中观察到的认知功能下降的程度相当或更大，这表明这些干预措施有可能扭转与年龄相关的认知功能下降。训练效果对日常活动(即功能能力)的影响很小。然而，应该指出的是，通过两年的随访，没有证据表明ADL和IADL的地位有显著下降。因此，要充分了解培训干预的认知迁移效应，需要较长的随访期，特别是要了解受过培训和未受培训的参与者的日常活动随着时间的推移是否存在变化轨迹。Active的第二阶段被认为是一项后续研究，重点是衡量训练效果对认知功能和认知需求日常活动的长期影响。第二阶段的后续行动将包括一项评估，包括第一阶段测试后电池和临床评估。活动队列(n=2832)是一种特殊样本，包含对非裔美国人、社会经济贫困人口和高龄成年人的大量过度抽样。 Active第二阶段的具体目标是：1)确定认知干预(作为初始治疗或作为反复强化的结果)是否对功能结果具有长期保护作用；2)记录认知训练向次要结果的任何延迟转移；以及3)确定影响干预反应的个体因素。 与第一阶段一样，检测治疗对认知和功能能力的影响的主要分析方法将是包含所有设计特征的重复测量、混合效果模型。 固定效应为固定效应，个体水平变异性为随机效应。其他多变量分析，包括使用潜在变化分析对变化的滞后和交叉滞后分析、结构方程建模和增长曲线分析，也将适当地用于表征个别差异因素与功能能力变化之间的关系。保守地预测保留率为72%，其中65%的队列提供完整数据，另有7%的人在第5年提供部分数据。功效分析表明，扩大研究范围将有可能观察到0.05-0.10数量级的优秀功效，至少在80%-90%的范围内。

DESCRIPTION (provided by applicant): This application is a renewal of the application titled "Trial of a Cognitive Intervention for Older Adults-CC". This application is for the Coordinating Center. Phase I of ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly) was a randomized controlled trial of three cognitive intervention arms, addressing the question of whether improving basic cognition aided in maintaining functional independence in elders. As to be reported in JAMA (11/12/02), Phase I found strong, broad and durable cognitive ability-specific training effects. The effect sizes were comparable to or greater than the amount of cognitive decline observed in other longitudinal studies, suggesting that the interventions have the potential to reverse age-related decline. There was minimal transfer of training effects to everyday activities (i.e., functional competence). However, it should be noted that through the two-year followup, there was no evidence of a significant decline in ADL and IADL status. Therefore, to adequately understand the cognitive transfer effects of the training interventions requires a longer followup period, particularly to see whether there is a separation of the change trajectories for everyday activities of trained and untrained participants over time. Phase II of ACTIVE is proposed as a followup study focused on measuring the long-term impact of training effects on cognitive function and cognitively demanding everyday activities. The Phase II followup will consist of one assessment to include the Phase I post-test battery and a clinical assessment. The ACTIVE cohort (n = 2832) is a special sample, containing substantial oversampling of African American, socioeconomically poor, and very old adults. The Specific Aims of Phase II of ACTIVE are: 1) to determine whether the cognitive interventions (as initlal treatment or as a consequence of repeated boosters) have long-term protective effects on functional outcomes; 2) to document any delayed transfer of the cognitive training to secondary outcomes; and 3) to identify individual factors that affect response to intervention. As in Phase I, the primary analytical approach to detecting treatment effects on both cognitive and functional abilities will be a repeated-measures, mixed-effects model incorporating all design features as fixed effects and individual-level variability as random effects. Other multivariate analyses including lagged and cross-lagged analyses of change using latent change analysis, structural equation modeling, and growth curve analyses will also be used as appropriate to characterize relationships between individual difference factors and change in functional competence. Retention is projected conservatively at 72% with 65% of the cohort providing full data and another 7% providing partial data at year 5. Power analysis shows that extending the study will make it possible to observe effect sizes on the order of 0.05-0.10 with excellent power, in the range of at least 80-90%.