Holistic Evaluation to Advance Research in Dementia (HEARD): Phased Interdisciplinary Infrastructure Development and Pilot Studies

痴呆症高级研究的整体评估 (HEARD)：分阶段跨学科基础设施开发和试点研究

• 批准号: 10818100
• 负责人: Sheryl Zimmerman
• 金额: $ 11.57万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10818100
• 关键词: Holistic; Evaluation; Advance; Research; Dementia

Molony, Sheila L 1R21AG007481-01 Revised Abstract: There is a lack of measures available for domains of importance to individuals and families living with Alzheimer’s Disease (AD) and related dementias. Available measures that do have clinical importance may include abstract constructs and/or complex response formats (e.g. 7-point Likert-type or numerical scales) that are not optimal for persons with dementia. Interdisciplinary researchers are engaging in innovative, person-centered interventions grounded in therapeutic optimism but are constrained by instruments that primarily quantify negative behaviors, deficit, and decline, and/or by measuring broad constructs such as global quality of life. The NIH-PROMIS measures demonstrate the value of standardized, common datasets but they do not currently incorporate patient preferences and may not encapsulate the full range of positive outcomes. Persons living with AD would benefit from rigorous, multi-site psychosocial intervention trials using a common portfolio of robust measures sensitive to change and measures that capture modifiable aspects of living well with dementia over time. This project will develop the infrastructure for development, standardization and validation of new outcome measures and methods for psychosocial interventions in AD. Emphasis will be placed on measures that are clinically meaningful to persons living with AD as well as measures that capture modifiable elements of living with AD and related dementias. Measures that optimize longitudinal evaluation of psychosocial intervention for persons with co-occurring cognitive and sensory challenges will be prioritized. In the R21 phase, an interdisciplinary steering council comprised of persons living with AD, researchers and biostatisticians will convene focused expert panels and collaborate with an advisory board of researchers and clinicians. Using the principles of human-centered design, the council will identify priority outcome measures and create standards for design and testing of novel measures, methods, and technologies. In the R33 phase, prioritized measures and methods will be pilot tested. These will include self-report, carer-informed and observational measures. Products of this work will include: 1) Research guidelines for the development and testing of new measures for psychosocial intervention research and 2) Promising new measures, methods and technologies available for larger scale testing with goal of adding to the NIHPROMIS measure set. The dissemination of these products will enhance the existing research infrastructure and accelerate progress in psychosocial intervention research.

希拉？莫洛尼 1R21AG007481-01 修订摘要： 在对个人和家庭具有重要意义的领域缺乏措施 患有阿尔茨海默病（AD）和相关痴呆症。具有临床重要性的可用指标可能包括抽象结构和/或复杂的响应格式（例如7点Likert类型或数字量表），这些对痴呆患者来说不是最佳的。跨学科研究人员正在从事创新的，以人为本的干预措施，以治疗乐观主义为基础，但受到主要量化负面行为，赤字和下降的工具的限制，和/或通过测量广泛的结构，如全球生活质量。NIH-PROMIS指标证明了标准化、通用数据集的价值，但它们目前没有纳入患者的偏好，可能无法涵盖所有积极结果。AD患者将受益于严格的多地点心理社会干预试验，这些试验使用对变化敏感的强大措施和随时间推移捕获痴呆症患者生活良好的可修改方面的措施的共同组合。该项目将为AD心理社会干预的新结果措施和方法的开发、标准化和验证建立基础设施。重点将放在对AD患者有临床意义的措施以及捕获AD和相关痴呆患者生活中可改变因素的措施上。将优先采取措施，优化对同时存在认知和感官挑战的人进行心理社会干预的纵向评价。在R21阶段，由AD患者、研究人员和生物统计学家组成的跨学科指导理事会将召集重点专家小组，并与研究人员和临床医生组成的咨询委员会合作。使用以人为本的设计原则，理事会将确定优先的结果措施，并创建新措施，方法和技术的设计和测试标准。在R33阶段，将试点测试优先措施和方法。这些措施将包括自我报告、照顾者知情和观察措施。这项工作的成果将包括：1）心理社会干预研究的新措施的开发和测试的研究指南和2）有前途的新措施，方法和技术可用于更大规模的测试，目标是添加到NIHPROMIS措施集。这些产品的传播将加强现有的研究基础设施，加快心理社会干预研究的进展。