Addressing the Knowledge and Recruitment Gap in Alzheimer's Disease and Precision Medicine among Native People: An Innovative Randomized Controlled Trial

摘要 阿尔茨海默病(AD)是一种常见的痴呆症，但关于AD的风险和患病率的数据很少 在美国印第安人和阿拉斯加原住民(AI/ANS)中。精确医学(PM)具有检测和 治疗AD等疾病。PM结合了临床、基因组、生物标记物和环境因素的数据 有关于健康行为的数据，以评估特定疾病的个人风险。它可以最大限度地提高 量身定做的临床管理。然而，还没有研究表明人工智能/人工智能对交流的偏好 AD或PM学习的教育或招聘信息。人工智能/人工智能遇到通信障碍 参与研究，以及更喜欢有助于理解和沟通的视觉辅助工具 有原住民传统。2015年，奥巴马总统宣布了一项2.15亿美元的PM计划，强调 充分代表种族和族裔少数群体。2016年，NIH资助了8个医疗保健组织 召集一个100万人的队列，他们将与健康一起贡献血液和尿液样本， 将环境和生活方式数据存储到基于人口的PM研究存储库(The All Of We Research 计划)。我们将与一家受赠人合作- 亚利桑那大学/班纳健康-将招收 10,000个人工智能/人工智能--评估在凤凰城-图森临床设施招聘人工智能/人工智能的方法。AI/AN 告密者将帮助为广告和广告制作适合文化的招聘材料(小册子、数字故事) PM研究。最后，我们将对4,000名AI/ANS参与者进行务实的随机对照试验 我们所有人都是。参与者将收到关于AD和PM的标准教育手册以及 研究(控制)或具有相同信息的文化定制、图形丰富的小册子的重要性，以及 查看以AD(干预)上的AI/ANS的个人叙述为特色的数字故事。然后将邀请参与者 完成可选的AD-PM模块，以评估AD知识和态度、健康素养、种族 识别和认知。完成后，他们将加入其他对未来AD和PM感兴趣的AI/AN 研究，并将他们所有人的数据和生物谱与他们的AD-PM模块数据联系起来。我们的两个主要结果 将完成AD-PM模块并注册AD-PM队列。具体目标是：1) 评估UAZB计划中人工智能/人工智能的招聘策略，并解决可能影响的因素 实施我们的试验；2)创建关于AD和PM的文化定制材料，并评估其清晰度和 可接受性；3)进行随机对照试验，以测试这些材料对完成 AD-PM模块和AD-PM队列中的登记；以及4)确定AD-PM队列的患者级别预测因素 招生情况，并按年龄、性别 教育、文化认同和乡村生活。AD-PM队列将代表一个独特的资源来缓解 人工智能/人工智能在AD和PM研究中的代表性明显不足。结果将突出交流 促进或阻碍AI/AN招聘的战略，阐明有关AD和PM的知识差距

ABSTRACT Alzheimer's disease (AD) is a common form of dementia, but little data exist on the risk and prevalence of AD among American Indians and Alaska Natives (AI/ANs). Precision medicine (PM) has potential for detecting and treating diseases such as AD. PM combines data on clinical, genomic, biomarker, and environmental factors with data on health behaviors to assess individual risk of a given disease. It can maximize the effectiveness of tailored clinical management. However, no research has addressed AI/AN preferences for communicating educational or recruitment information for AD or PM studies. AI/ANs experience communication barriers to research participation, as well as prefer visual aids that assist comprehension and communication that align with Native traditions. In 2015, President Obama announced a $215 million PM initiative which emphasizes adequate representation of racial and ethnic minorities. In 2016, NIH funded 8 healthcare organizations to assemble a cohort of 1 million people who will contribute blood and urine samples along with health, environmental, and lifestyle data to a population-based repository for PM research (the All of Us Research Program). We will collaborate with one grantee – the University of Arizona/Banner Health – that will enroll 10,000 AI/ANs -- to evaluate methods to recruit AI/ANs at their Phoenix-Tucson clinical facilities. AI/AN informants will help create culturally appropriate recruitment materials (brochures, digital stories) for AD and PM research. Finally, we will conduct a pragmatic randomized controlled trial with 4,000 AI/ANs enrollees in the All of Us cohort. Participants will receive either a standard educational brochure on AD and PM and the importance of research (control) or a culturally tailored, graphics-rich brochure with identical information, and view a digital story featuring personal narratives of AI/ANs on AD (intervention). Participants will then be invited to complete an optional AD-PM Module to assesses AD knowledge and attitudes, health literacy, ethnic identify, and cognition. Upon completion, they will join other AI/ANs who are interested in future AD and PM research, and link their All of Us data and biospecimens to their AD-PM Module data. Our 2 primary outcomes will be completion of the AD-PM Module and enrollment in the AD-PM Cohort. The Specific Aims are to: 1) to evaluate recruitment strategies for AI/ANs in the UAZB program, and address factors that might affect implementation of our trial; 2) create culturally tailored materials on AD and PM, and evaluate their clarity and acceptability; 3) conduct a randomized controlled trial to test the effect of these materials on completion of the AD-PM Module and enrollment in the AD-PM Cohort; and 4) identify patient-level predictors of AD-PM Cohort enrollment, and evaluate potential differences in the effectiveness of recruitment approach by age, sex, education, cultural identity, and rurality. The AD-PM Cohort will represent a unique resource for alleviating the stark underrepresentation of AI/ANs in AD and PM research. Results will highlight communication strategies that facilitate or hinder AI/AN recruitment, elucidate knowledge gaps regarding AD and PM.