Computerized Activities of Daily Living System

日常生活活动计算机化系统

• 批准号: 6909909
• 负责人: JAMES P O'HALLORAN
• 金额: $ 17.27万
• 依托单位: NEUROCOMP SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-03-01 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6909909
• 关键词: Alzheimer' s disease; clinical research; cognition; computer assisted patient care; computer human interaction; computer program /software; computer system design /evaluation; computer system hardware; data collection methodology /evaluation; functional ability; human subject; information systems; interactive multimedia; interview; longitudinal human study; patient oriented research; personal log /diary

DESCRIPTION (provided by applicant): Alzheimer's Disease (AD) is a degenerative disorder of the central nervous system that affects between 4-6% of all elderly US residents over the age of 65, with annual associated costs to the US economy of over $100 billion. Research and development of new treatments is critically dependent on accurate and reliable assessment methods. Assessment of common daily living skills is an essential component of evaluation of new treatments for Alzheimer's disease in controlled, sponsored clinical trials. The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADLI) is the first comprehensive ADL instrument developed for the purpose of evaluating new AD treatments and is applied in over 87% of all clinical trials of new antidementia pharmacologic agents. An equivalent, computerized version of the ADLI would find immediate, widespread application in controlled clinical trials and related research protocols of new pharmaceutical agents aimed at reducing the cognitive deficits and underlying neuropathology of Alzheimer's disease. The objective of Phase II is to complete the development of an advanced computerized ADLI system capable of acquiring data at the point of patient contact and that includes a suite of utilities for implementation and management of AD clinical trials, as well as related research protocols. Both examiner-administered and self-administered modes will be developed. To maximize application capability in a variety of settings, three computer platforms will be supported: desktop, notebook and tablet PC. Advantages of the computerized ADLI (cADLI) system include: increased data quality through standardized administration, automated reporting and documentation, automated linkage to patient tracking and scheduling, automated protocol compliance, reduced examiner requirements and errors, automatic generation and tracking of CRFs, automated electronic database transfer and reduced costs. In addition to software completion, Phase II will implement consecutive studies in human subjects to optimize the self-administered form and determine longitudinal concurrent validity of the standard ADLI with the computerized ADLI at a leading AD research center. The proposed new system will provide the first ever computerized ADL instrument for clinical trials and first self-administered version. The final, validated version will comply with specialized FDA, HHS and HIPAA regulations and guidelines.

描述（由申请人提供）：阿尔茨海默病（AD）是一种中枢神经系统退行性疾病，影响4%-6%的65岁以上的美国老年居民，每年给美国经济带来的相关成本超过1000亿美元。新疗法的研究和开发严重依赖于准确可靠的评估方法。日常生活技能的评估是在受控的、赞助的临床试验中评估阿尔茨海默病新疗法的重要组成部分。阿尔茨海默病合作研究日常生活活动量表（ADLI）是第一个为评估新的AD治疗而开发的综合性ADL工具，并应用于超过87%的新抗痴呆药物的所有临床试验。一个等效的，计算机化版本的ADLI将发现立即，广泛应用于控制的临床试验和相关的研究方案的新药物，旨在减少认知缺陷和潜在的神经病理学阿尔茨海默氏病。 第二阶段的目标是完成先进的计算机化ADLI系统的开发，该系统能够在患者接触点采集数据，包括一套用于实施和管理AD临床试验的实用程序，以及相关的研究方案。将开发检查员管理和自我管理模式。为了在各种环境中最大限度地发挥应用能力，将支持三种计算机平台：台式机、笔记本电脑和平板电脑。计算机化ADLI（cADLI）系统的优势包括：通过标准化管理提高数据质量、自动报告和记录、自动链接到患者跟踪和安排、自动方案合规性、减少检查员要求和错误、自动生成和跟踪CRF、自动电子数据库传输和降低成本。除了软件完成，第二阶段将在人类受试者中实施连续研究，以优化自我管理的形式，并确定标准ADLI与领先AD研究中心的计算机化ADLI的纵向并行有效性。拟议的新系统将提供有史以来第一个计算机化的ADL仪器的临床试验和第一个自我管理的版本。最终验证版本将符合FDA、HHS和HIPAA的专门法规和指南。