ACTIVE Phase III: IU Field Site

说明(申请人提供)：这项建议扩大了对接受认知干预的老年人和高龄老年人的后续行动，这是积极(独立和有活力的老年人高级认知培训)的一部分。五年的研究结果表明，干预对认知能力的影响是持久的，而且这些干预效果已经转移到了假设的IADL功能的维持上。这一扩展后续行动的具体目标是：1)确定认知干预措施在最初培训后10年内是否继续具有保护作用：a)记忆、推理和速度或处理的基本认知能力；b)自我报告和基于绩效的日常生活工具活动；c)与健康相关的生活质量。2)确定认知干预是否对驾驶安全、日常生活中的个人护理活动、卫生服务利用和死亡率的远端结果有有利影响。3)考察个体对训练反应的健康、遗传和认知调节因素，包括认知功能低下、心血管状况、参与度和载脂蛋白E基因型等因素。4)通过将积极训练的措施和结果与健康和退休研究联系起来，估计和预测积极训练对一般老年人的影响。这一建议提供了一个独特的机会，可以前瞻性地研究三种类型的认知干预对这一特征良好的队列中功能下降的滞后影响，由于年龄的增加，现在面临着IADL和ADL下降的迫在眉睫的风险。我们将能够在这项研究中测试基本问题：对于接受这些认知干预的老年人来说，随着受试者年龄增长到80多岁，关键日常活动中的残疾能否推迟，独立性能否保持。我们估计，在10年内，认知能力、日常问题解决能力和日常速度的影响大小为0.2，日常功能的影响大小为0.4。这项积极的研究将确定认知训练是否可以帮助老年人在更长一段时间内继续发挥功能和独立生活。 本申请是题为“认知ADL的维护和增强”的应用程序的续订。这份申请是针对印第安纳大学的实地考点。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，为了充分了解培训干预措施的认知迁移效应，需要更长的随访期，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一种重复测量的混合效果模型，将所有设计特征作为固定效果，将个体水平的可变性作为随机效果。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 proposal extends follow-up of old and very-old persons who have received cognitive interventions as part of ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). Findings at five years indicate the effects of the intervention on cognitive abilities are durable and that these intervention effects have transferred to maintenance of IADL function as hypothesized. The Specific Aims of this extended follow-up are to: 1) To determine if the cognitive interventions continue to have protective effects up to 10 years after initial training: a) basic cognitive abilities of memory, reasoning, and speed or processing; b) self- reported and performance-based instrumental activities of daily living; and c) health-related quality of life. 2) To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality. 3) To examine heath, genetic and cognitive moderators in individual response to training, including such factors as low cognitive function, cardiovascular status, engagement, and ApoE genotype. 4) To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study. This proposal affords a unique opportunity to prospectively study lagged effects of three types of cognitive interventions on functional decline in this well-characterized cohort that, given its advancing age, is now at imminent risk for both IADL and ADL decline. We will be able to test the basic question in this study: For older adults exposed to these cognitive interventions, can disability in the performance of key everyday activities be delayed and independence maintained as subjects age into their 80s. We estimate power to detect effect sizes of 0.2 over 10 years for the cognitive abilities, everyday problem solving, and everyday speed and an effect size of 0.4 for everyday functioning. The ACTIVE study will determine if cognitive training can help older adults to continue functioning and living independently for a longer period of time. This application is a renewal of the application titled "Maintenance and Enhancement of Cognitive ADLs". This application is for the Field Site at Indiana University. 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, a longer followup period is required, 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 initial 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%.