TRIAL OF A COGNITIVE INTERVENTION FOR OLDER ADULTS--CC

描述：NERI要求提供五年的支持，以成为 进行临床试验开发的场地协调中心 认知干预和其他干预措施，帮助老年人保持 保持更长时间的独立。这个项目的总体目标是 合作多点现场试验是为了测试一种认知或 相关的知觉、动机或态度干预 在不同的高危老年人群体中独立运作。更多 具体地说，本次现场试验的目的包括1)设计一种通用的 适合目标人群的认知干预；2)设计 评估干预效果的评估策略；以及3) 实施干预并进行随机试验以确定 功效。该协调中心将在以下方面提供领导和专业知识 以下领域：1)提供技术援助，以设计和 评估干预措施，包括制定核心衡量标准 2)设计供野战中心使用的数据管理系统， 包括对员工的培训和监督；3)提高质量 控制活动，包括编制操作手册和 表格，以及对外地工作人员的培训和监测，以确保标准 在所有地点执行共同协议；4)监测数据 收购以确保高质量的分析数据库；5)主要 对试验结果的分析，包括将进程措施整合到 评估治疗的保真度；以及6)沟通和会议支持。 NERI调查人员此前曾进行过协调中心 在复杂的多点试验中的活动。此外，NERI还配备了 以及设计和分析非标准试验所需的专业知识 使用过程测量集成和数据管理系统(集中式 和分布式)和随机化。

DESCRIPTION: Five years of support are requested by the NERI to become a coordinating center for sites which conduct clinical trials to develop cognitive and other interventions to help older persons maintain independence for longer periods of time. The overall goal of this cooperative multisite field trial is to test the efficacy of a cognitive or related perceptual, motivational, or attitudinal intervention in promoting independent functioning in a diverse group of at-risk older adults. More specifically, the aims of this field trial include 1) designing a common cognitive intervention appropriate for the target population; 2) designing an evaluation strategy to assess the efficacy of the intervention; and 3) implementing the intervention and conducting a randomized trial to determine efficacy. This coordinating center will provide leadership and expertise in the following areas: 1) providing technical assistance in designing and evaluating the intervention, including development of a core measurement battery; 2) designing a data management system for use by the field centers, including training and monitoring of their staff; 3) developing quality control activities, including development of a manual of operations and forms, and training and monitoring of the field staff to ensure standard implementation of the common protocol across the sites; 4) monitoring data acquisition to ensure high quality databases for analyses; 5) primary analyses of trial outcomes, including integration of process measures to assess treatment fidelity; and 6) communication and meeting support. The NERI investigators have previously conducted coordination-center activities in complex multisite trials. In addition, the NERI has equipment and expertise required for the design and analysis of non-standard trials with process measure integration and data management systems (centralized and distributed) and randomization.