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.

莫洛尼，希拉 L 1R21AG007481-01 修订后的摘要： 对于对个人和家庭重要的领域缺乏可用的措施 患有阿尔茨海默病 (AD) 和相关痴呆症。确实具有临床重要性的可用测量可能包括抽象结构和/或复杂的反应格式（例如 7 点李克特型或数字量表），这些对于痴呆症患者来说并不是最佳的。跨学科研究人员正在从事以治疗乐观主义为基础的创新的、以人为本的干预措施，但受到主要量化消极行为、缺陷和衰退和/或衡量全球生活质量等广泛结构的工具的限制。 NIH-PROMIS 措施证明了标准化、通用数据集的价值，但它们目前并未纳入患者偏好，也可能无法概括所有积极结果。阿尔茨海默病患者将受益于严格的、多地点的社会心理干预试验，这些试验使用了一系列对变化敏感的强有力的措施，以及随着时间的推移捕捉痴呆症患者良好生活的可改变方面的措施。该项目将为 AD 心理社会干预的新结果测量和方法的开发、标准化和验证开发基础设施。重点将放在对阿尔茨海默病患者有临床意义的措施以及捕捉阿尔茨海默病和相关痴呆症患者可改变因素的措施上。将优先考虑对同时存在认知和感觉挑战的人进行心理社会干预的纵向评估的优化措施。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委员会将召集有重点的专家小组，并与研究人员和临床医生的顾问委员会合作。委员会将利用以人为本的设计原则，确定优先成果措施，并制定新措施、方法和技术的设计和测试标准。 R33阶段将试点优先措施和方法。这些措施包括自我报告、照顾者知情和观察措施。这项工作的产品将包括：1）用于开发和测试社会心理干预研究新措施的研究指南；2）有前景的新措施、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。这些产品的传播将增强现有的研究基础设施，并加速社会心理干预研究的进展。