UNDERSTANDING HOW THE STUDY PARTNER REQUIREMENT IMPACTS THE DISCOVERY AND TRANSLATION OF PRECLINICAL ALZHEIMERS DISEASE

了解研究合作伙伴要求如何影响临床前阿尔茨海默病的发现和转化

• 批准号: 9980755
• 负责人: Emily Largent
• 金额: $ 12.73万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9980755
• 关键词: Address; Adult; Affect; Alzheimer' s Disease; Alzheimer' s disease care; Alzheimer’s disease biomarker; Amyloid; Amyloid beta-Protein; Attention; Attitude; Behavioral; Belief; Biological Assay; Biological Markers; Brain; Characteristics; Clinical Research; Cognition; Cognitive; Data; Decision Making; Discipline of Nursing; Disclosure; Disease; Elderly; Empirical Research; Enrollment; Ethics; Ethnic Origin; Funding Mechanisms; Future; Gender; Generations; Goals; Grant; Hand; Health; Individual; Intention; Interview; K-Series Research Career Programs; Knowledge; Label; Laws; Learning; Mentors; Methods; Modality; Nature; Nerve Degeneration; Participant; Pennsylvania; Policies; Population; Prevention; Principles of law and justice; Race; Research; Research Ethics; Research Methodology; Research Personnel; Research Training; Resources; Role; Series; Socioeconomic Status; Spouses; Structure; Surveys; Testing; Training; Training Activity; Translations; Universities; Well in self; aged; career; clinical practice; design; experience; informant; innovation; insight; meetings; multidisciplinary; novel; pre-clinical; preclinical study; pressure; prospective; psychologic; psychological distress; psychosocial; racial difference; recruit; research to practice; skills; tau Proteins; tau aggregation

The applicant’s career goal is to be an independent investigator whose research assures the successful, ethically-informed translation of the preclinical Alzheimer’s disease construct into clinical practice. As a first step toward that goal, the applicant seeks to answer a fundamental question: how does the requirement that participants in preclinical Alzheimer’s disease trials enroll with a knowledgeable informant or “study partner” affect diverse recruitment and the study partners themselves? This question is important because until it is answered, it will be difficult to meet the overarching goal of the NIA’s National Strategy for Recruitment and Participation in Alzheimer’s Disease Clinical Research, which is to engage broad segments of the population in research to better understand and eventually cure Alzheimer’s disease. The overall objective in this application is to understand the effects of the study partner requirement in preclinical Alzheimer’s disease research. The central hypothesis is that race, gender, and the nature of the relationship between the participant and the study partner (i.e., spousal/non-spousal) affect both the availability of a study partner to participate and the study partner’s research experience. The rationale for the proposed research is that understanding the effects of the study partner requirement has the potential to facilitate diverse recruitment and inform the future of biomarker disclosure in clinical practice. Guided by strong preliminary data, the applicant will test this hypothesis by pursuing three specific aims: (1) Describe how a study partner’s knowledge of a preclinical Alzheimer’s disease trial participant’s brain amyloid status influences the study partner’s psychological well-being and planning for the future, and examine the differences by race, gender, and relationship. (2) Characterize the role of the study partner in the preclinical Alzheimer’s disease trial enrollment decision, and examine the differences by race, gender, and relationship. (3) Identify psychosocial determinants associated with the intention to ask someone to serve as a study partner in a preclinical Alzheimer’s disease trial, the beliefs associated with those determinants, and the differences in intention by race, gender, and relationship. Under the first and second aims, individual interviews, which have already been established as feasible in the applicant’s hands, will be used to understand key aspects of the study partner experience. Under the third aim, the applicant will conduct a nationally-representative survey of older adults. This approach is innovative because it departs from the status quo by focusing on study partners rather than exclusively on preclinical Alzheimer’s disease trial participants. The proposed research is significant because it is expected to inform the design of preclinical Alzheimer’s disease trials to enhance recruitment and biomarker disclosure practices. The training activities during the grant period have been designed to advance the applicant’s career goal and will build on expertise in research ethics, health law, policy, and nursing, refine knowledge of research methods, and develop critical knowledge of Alzheimer’s disease care and research.

申请人的职业目标是成为一名独立的调查员，其研究确保成功， 将临床前阿尔茨海默病结构转化为临床实践。作为第一 为了实现这一目标，申请人试图回答一个基本问题： 临床前阿尔茨海默病试验的参与者与知识渊博的知情人或“研究伙伴”一起登记 会影响多样性招募和研究伙伴本身吗？这个问题很重要，因为直到它是 回答，这将是难以实现的总体目标，NIA的国家战略招聘， 参与阿尔茨海默病临床研究，这是为了让广泛的人群参与 研究，以更好地了解并最终治愈阿尔茨海默病。在这方面的总体目标 应用是为了了解临床前阿尔茨海默病的研究伙伴要求的影响 research.中心假设是，种族、性别和性别之间的关系的性质， 参与者和研究伙伴（即，配偶/非配偶）影响研究伴侣的可用性， 参与和研究伙伴的研究经验。拟议研究的理由是， 了解研究伙伴要求的影响有可能促进多样化的招募 并为临床实践中生物标志物披露的未来提供信息。在强有力的初步数据的指导下， 申请人将通过追求三个具体目标来测试这一假设：（1）描述研究伙伴的 临床前阿尔茨海默病试验参与者的脑淀粉样蛋白状态的知识影响了研究 伴侣的心理健康和对未来的规划，并检查种族，性别， 和关系。(2)描述研究伙伴在临床前阿尔茨海默病试验中的作用 招生决定，并检查种族，性别和关系的差异。(3)确定社会心理 与邀请某人担任临床前研究合作伙伴的意图相关的决定因素 阿尔茨海默病试验，与这些决定因素相关的信念，以及 种族性别和关系在第一和第二个目标下，个别访谈，这已经是 在申请人手中建立可行的，将用于了解研究合作伙伴的关键方面 体验.根据第三个目标，申请人将对老年人进行一次全国性的代表性调查。 这种方法是创新的，因为它通过关注学习伙伴而不是 专门针对临床前阿尔茨海默病试验参与者。这项研究意义重大，因为 它有望为临床前阿尔茨海默病试验的设计提供信息，以加强招募， 生物标志物披露实践。赠款期间的培训活动旨在促进 申请人的职业目标，并将建立在研究伦理，卫生法，政策和护理，完善专业知识， 研究方法的知识，并发展阿尔茨海默病护理和研究的关键知识。