Establishing the science behind Alzheimer's recruitment registries: opportunities for increasing diversity and accelerating enrollment into trials

建立阿尔茨海默病招募登记背后的科学：增加多样性和加速试验注册的机会

• 批准号: 10006092
• 负责人: Amy Bleakley
• 金额: $ 161.69万
• 依托单位: BANNER HEALTH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10006092
• 关键词: Address; Adult; African American; Age; Alzheimer disease prevention; Alzheimer' s Disease; Attention; Attitude; Behavior; Behavior Control; Behavioral Model; Belief; Brain Health Registry; Clinical Research; Clinical Trials; Data; Decision Making; Elderly; Enrollment; Environment; Ethnic Origin; Female; Focus Groups; Gender; Goals; Health; Hispanics; Intention; Intervention; Interview; Laboratories; Learning; Measures; Medical; Minority; Monitor; Not Hispanic or Latino; Participant; Prevention trial; Process; Public Health; Race; Reaction; Registries; Research; Sampling; Science; Series; Structure; Surveys; Target Populations; Testing; Time; United States; Variant; base; design; ethnic minority population; evidence base; male; men; psychosocial; racial minority; recruit; screening; theories; tool; willingness

Project Summary/Abstract The suffering caused by Alzheimer’s disease (AD) remains one of the greatest unmet medical needs of our times. With a heightened sense of urgency, numerous AD prevention trials are being launched, requiring an unprecedented number of healthy older adults to be screened to identify the thousands eligible to participate. Recognizing this obstacle, initiatives such as the National Plan to Address AD call for greater attention to 1) increasing enrollment into clinical trials and other clinical research, and 2) monitoring and identifying strategies to increase enrollment of racial and ethnic minorities in AD studies. An outgrowth of the National Plan is the National Strategy for Recruitment and Participation in Alzheimer's Disease Clinical Research which recognizes the requirement for developing and understanding a new “science of recruitment.” Recently, multiple AD recruitment registries have been developed, including but not limited to the Alzheimer’s Prevention Registry, GeneMatch, the Brain Health Registry, and GenePool. Although each differs in what they require of participants in terms of information and time commitment (herein referred to as “tiers of participation”), the registries share a common goal of accelerating enrollment into AD studies. However, despite enrolling >450,000 across all four registries, enrollees in each registry are predominantly female and non-Hispanic / white, thereby perpetuating the lack of diversity among AD prevention trial participants. The objective of this proposal is to understand how to effectively communicate the importance of AD prevention trial participation to men and minorities. This proposal will accomplish this objective via the following aims: 1) using semi-structured interviews and a nationally representative survey to identify the relevant psychosocial determinants (attitudes, norms, efficacy/control) for each “tier of participation” and understanding how they vary by race/ethnicity and gender; 2) develop and test evidence-based messaging to join each registry via iterative concept testing via focus groups enriched for men and minorities and online message testing to assess persuasiveness, and 3) deploy evidence-based messages into our real-word testing environment, measuring their impact on enrollment of men and minorities into each registry and enrollees’ subsequent willingness to participate in AD prevention trials. We hypothesize that enrollment of men and minorities into each registry will increase, with positive downstream effects on diversity among AD prevention trial participants.

项目摘要/摘要 阿尔茨海默病(AD)造成的痛苦仍然是我们最大的未得到满足的医疗需求之一 泰晤士报。随着紧迫感的增强，许多AD预防试验正在启动，需要 将对数量空前的健康老年人进行筛查，以确定数千名有资格参与的人。 认识到这一障碍，诸如应对AD的国家计划等倡议呼吁更多地关注1) 增加临床试验和其他临床研究的登记人数；2)监测和确定战略 增加种族和少数民族在AD研究中的入学人数。国家计划的一个副产品是 招募和参与阿尔茨海默病临床研究国家战略 发展和理解一门新的“招聘学”的要求。最近，多个AD 已经建立了招募登记册，包括但不限于阿尔茨海默氏症预防登记处， GeneMatch、大脑健康注册中心和基因池。尽管每个人对参与者的要求都不同 在信息和时间承诺方面(这里称为“参与层级”)，各登记处共享 加速攻读AD研究的共同目标。然而，尽管这四所学校都招收了450,000名学生 在登记处，每个登记处的登记人主要是女性和非西班牙裔/白人，从而使 阿尔茨海默病预防试验参与者缺乏多样性。这项建议的目标是了解如何 有效地向男性和少数民族宣传参与AD预防试验的重要性。这 提案将通过以下目标实现这一目标：1)使用半结构化面试和全国范围内的 确定有关心理社会决定因素(态度、规范、效果/控制)的代表性调查 每个“参与层次”，并了解它们如何因种族/民族和性别而异；2)开发和测试 基于证据的消息传递，通过迭代概念测试，通过为男性丰富的焦点小组加入每个注册中心 和少数族裔和在线消息测试，以评估说服力，以及3)部署基于证据的消息 进入我们真实的测试环境，衡量他们对男性和少数族裔入学的影响 登记和参与者随后参与AD预防试验的意愿。我们假设 男性和少数群体进入每个登记处的人数将会增加，对多样性有积极的下游影响 在AD预防试验参与者中。