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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：
10403518
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/10403518
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

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名独立的研究者，他的研究保证了成功。