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.

莫尔尼，希拉·L 1R21AG007481-01 修订摘要： 缺乏对个人和家庭重要领域的措施 患有阿尔茨海默氏病（AD）和相关痴呆症。确实具有临床重要性的可用措施可能包括抽象构造和/或复杂的响应格式（例如7点李克特类型或数值尺度），这些格式对于痴呆症患者而言并非最佳。跨学科的研究人员正在从事以治疗乐观为基础的创新，以人为本的干预措施，但受到原始量化负面行为，赤字和衰落和/或通过测量诸如全球生活质量等广泛结构的工具的约束。 NIH-Promis措施证明了标准化的，常见数据集的价值，但目前尚未纳入患者的偏好，并且可能不会封装全部阳性结果。拥有AD的人将使用严格的多站点的心理心理干预试验受益，该试验使用对变化敏感的强大测量组合，并捕获了随着时间的推移而与痴呆症相关的修改方面的措施。该项目将开发用于开发，标准化和验证新成果指标的基础架构和AD心理干预方法的方法。重点将放在对拥有AD的人以及捕获可修改AD和相关痴呆症的可修改要素的措施上具有临床意义的测量值。优化对具有共同认知和感觉挑战的人的心理干预纵向评估的措施将优先考虑。在R21阶段，跨学科的指导委员会结束了与AD，研究人员和生物统计学家同住的人，将方便地专注于专家小组，并与研究人员和临床医生的顾问委员会合作。使用以人为本的设计原则，理事会将确定优先结果指标，并为新颖措施，方法和技术的设计和测试创建标准。在R33阶段，将测试优先级的测量和方法。这些将包括自我报告，载体信息和观察措施。这项工作的产品将包括：1）开发和测试社会心理干预研究的新措施的研究指南； 2）有望采用的新措施，方法和技术可用于大规模测试，目标是增加NIHPROMIS测量集。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。