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.
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