ACTIVE Phase II: Coordinating Center

描述（由申请人提供）：本申请是对题为“老年人认知干预试验-CC”的申请的更新。这是协调中心的申请。ACTIVE（独立和活力老年人高级认知训练）的第一阶段是一项随机对照试验，涉及三个认知干预组，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性的问题。正如JAMA（11/12/02）所报道的那样，第一阶段发现了强大，广泛和持久的认知能力特定的训练效果。效应量与其他纵向研究中观察到的认知能力下降量相当或更大，这表明干预措施有可能逆转与年龄相关的下降。训练效果很少转移到日常活动中（即，职能能力）。然而，应该注意的是，通过两年的随访，没有证据表明ADL和IADL状态显著下降。因此，要充分了解培训干预的认知转移效果，需要更长的随访时间，特别是要了解经过培训和未经培训的参与者的日常活动的变化轨迹是否随时间而分离。ACTIVE的第二阶段是一项后续研究，重点是测量训练对认知功能和认知要求较高的日常活动的长期影响。II期随访将包括一项评估（包括I期试验后组合）和一项临床评估。ACTIVE队列（n = 2832）是一个特殊的样本，包含大量的非裔美国人，社会经济贫困，非常老的成年人。 ACTIVE II期的具体目的是：1）确定认知干预（作为初始治疗或作为重复加强剂的结果）是否对功能结局具有长期保护作用; 2）记录认知训练向次要结局的任何延迟转移; 3）确定影响干预反应的个体因素。 与I期研究一样，检测治疗对认知和功能能力影响的主要分析方法将是一种包含所有设计特征的重复测量混合效应模型 作为固定效应，个体水平的变异性作为随机效应。其他多变量分析，包括采用潜在变化分析、结构方程模型和增长曲线分析的滞后和交叉滞后变化分析，也将酌情用于表征个体差异因素与功能能力变化之间的关系。保守预测保留率为72%，其中65%的队列提供了完整数据，另外7%提供了第5年的部分数据。功效分析表明，扩展研究将使观察到0.05-0.10量级的效应量成为可能，具有极好的功效，范围至少为80- 90%。

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%.