ACTIVE Phase II: Coordinating Center

描述（由申请人提供）：此申请是申请标题为“老年人认知干预试验- cc”的更新。这是给协调中心的申请。ACTIVE （Advanced Cognitive Training for Independent and Vital Elderly）的第一阶段是一项随机对照试验，涉及三个认知干预组，研究改善基本认知是否有助于维持老年人的功能独立性。据JAMA（11/12/02）报道，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。效应大小与其他纵向研究中观察到的认知衰退相当或更大，表明干预措施有可能逆转与年龄相关的衰退。将训练效果转移到日常活动（即功能能力）的可能性很小。然而，值得注意的是，通过两年的随访，没有证据表明ADL和IADL状态明显下降。因此，要充分了解训练干预的认知转移效应，需要更长的随访期，特别是要观察训练和未训练参与者的日常活动变化轨迹是否随着时间的推移而分离。ACTIVE的第二阶段是一项跟踪研究，旨在测量训练对认知功能和认知要求日常活动的长期影响。II期随访将包括一个评估，包括I期后测试电池和临床评估。ACTIVE队列（n = 2832）是一个特殊的样本，包含大量非裔美国人、社会经济贫困人群和高龄成年人的过采样。

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%.