TRIAL OF A COGNITIVE INTERVENTION FOR OLDER ADULTS--CC

描述：NERI要求五年的支持，以成为一个 开展临床试验的研究中心协调中心， 认知和其他干预措施，以帮助老年人 独立更长的时间。 这个项目的总体目标是 合作性多地点田间试验是为了测试认知或 相关的知觉，动机，或态度的干预，促进 独立运作在一个不同的群体中的风险老年人。 更 具体而言，该田间试验的目的包括：1）设计一种通用的 适合目标人群的认知干预; 2）设计 评估干预措施有效性的评价策略;以及3） 实施干预措施并进行随机试验， 功效 该协调中心将提供领导和专业知识， （1）提供技术援助， 评估干预措施，包括制定核心衡量标准 电池; 2）设计供现场中心使用的数据管理系统， 包括培训和监督其工作人员; 3）发展质量 控制活动，包括制定业务手册， 表格，培训和监测外地工作人员，以确保标准 在各研究中心实施共同方案; 4）监测数据 采购以确保高质量的分析数据库; 5）主要 分析试验结果，包括整合过程措施， 评估治疗保真度; 6）沟通和会议支持。 NERI的调查人员此前曾进行过协调中心 复杂多中心试验中的活动。 此外，NERI还拥有设备， 设计和分析非标准试验所需的专业知识 过程测量集成和数据管理系统（集中式 和分布）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.