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: 9806426
• 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/9806426
• 关键词: Address; Adult; Affect; Alzheimer' s Disease; Alzheimer’s disease biomarker; Amyloid; Amyloid beta-Protein; Attention; Attitude; Behavioral; Belief; Biological Assay; Biological Markers; Brain; Caring; 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.

申请者的职业目标是成为一名独立的调查员，其研究确保成功的， 临床前阿尔茨海默病的伦理信息转化为临床实践。作为第一次 迈向这一目标，申请人试图回答一个基本问题：如何要求 阿尔茨海默病临床前试验的参与者向消息灵通的线人或“研究伙伴”登记 会不会影响多元化的招聘和学习伙伴本身？这个问题很重要，因为在此之前 回答说，很难实现NIA国家招聘和发展战略的总体目标 参与阿尔茨海默病临床研究，这是为了让广大人口在 更好地了解并最终治愈阿尔茨海默氏症的研究。这个项目的总体目标是 应用于了解研究伙伴要求在临床前阿尔茨海默病中的作用 研究。中心假设是种族、性别和自然之间的关系 参与者和研究伙伴(即配偶/非配偶)都会影响研究伙伴的可用性 参与和学习伙伴的研究经历。建议进行这项研究的理由是 了解学习伙伴要求的影响有可能促进多样化的招聘 并对未来临床实践中生物标记物的披露进行了展望。在强劲的初步数据指引下， 申请者将通过追求三个具体目标来检验这一假设：(1)描述研究伙伴如何 对阿尔茨海默病临床前试验参与者大脑淀粉样蛋白状态的了解影响研究 伴侣的心理健康状况和对未来的规划，并按种族、性别、 和关系。(2)描述研究伙伴在阿尔茨海默病临床前试验中的作用 招生决定，并按种族、性别和关系检查差异。(3)识别心理社会 与邀请某人作为临床前研究伙伴的意向相关的决定因素 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，个人采访已经 在申请人手中建立可行的，将被用来了解研究伙伴的关键方面 经验。根据第三个目标，申请者将对老年人进行一项具有全国代表性的调查。 这种方法是创新的，因为它改变了现状，专注于研究伙伴，而不是 独家报道临床前阿尔茨海默病试验参与者。这项拟议的研究具有重要意义，因为 预计它将为阿尔茨海默病临床前试验的设计提供信息，以加强招募和 生物标记物披露实践。赠款期间的培训活动旨在推进 申请者的职业目标，并将建立在研究伦理，卫生法律，政策和护理方面的专业知识，完善 了解研究方法，发展阿尔茨海默病护理和研究的关键知识。