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

基本信息

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
项目类别：
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&apos s Disease Alzheimer&apos 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

Address Adult Affect Alzheimer&apos s Disease Alzheimer&apos 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

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项目摘要

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个独立研究者，其研究假设成功，伦特林阿尔茨海默氏病构建为临床实践的道德信息翻译。首先朝着这个目标迈出一步，申请人试图回答一个基本问题：参加临床前阿尔茨海默氏病试验的参与者参加了知识渊博的线人或“学习伙伴” 影响潜水员的招聘和研究伙伴本身？这个问题很重要，因为直到回答说，很难实现NIA国家招募战略和参与阿尔茨海默氏病临床研究，该研究将参与广泛的人群研究以更好地理解并最终治愈阿尔茨海默氏病。总体目标应用是了解研究伙伴要求对临床前阿尔茨海默氏病的影响研究。中心假设是种族，性别和关系的性质参与者和研究伙伴（即配偶/非配偶）都会影响研究伙伴的可用性参加和研究伙伴的研究经验。拟议研究的理由是了解研究合作伙伴要求的影响有可能促进潜水员招募并在临床实践中告知生物标志物披露的未来。在强大的初步数据的指导下申请人将通过追求三个具体目标来检验这一假设：（1）描述研究伙伴的方式了解临床前阿尔茨海默氏病试验参与者的大脑淀粉样蛋白状况会影响该研究伴侣对未来的心理健康和计划，并通过种族，性别，和关系。（2）表征研究伴侣在临床前阿尔茨海默氏病试验中的作用注册决策，并检查种族，性别和关系的差异。（3）识别社会心理与打算要求某人担任临床前学习伙伴有关的决定因素阿尔茨海默氏病试验，与这些决定者相关的信念以及意图上的差异种族，性别和关系。在第一个和第二个目标下，个人访谈已经存在在申请人手中可行的确定，将用于了解研究合作伙伴的关键方面经验。在第三个目标下，申请人将对老年人进行全国代表性的调查。这种方法具有创新性，因为它通过专注于学习伙伴而不是专门针对临床前阿尔茨海默氏病试验参与者。拟议的研究很重要，因为预计将为临床前阿尔茨海默氏病试验的设计提供信息，以增强招聘和生物标志物披露实践。赠款期间的培训活动旨在提高申请人的职业目标，并将基于研究伦理，卫生法，政策和护士的专业知识，研究方法的知识，并发展对阿尔茨海默氏病护理和研究的批判性知识。