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

解决原住民中阿尔茨海默病和精准医学的知识和招募缺口：一项创新的随机对照试验

• 批准号: 9926735
• 负责人: DEDRA S BUCHWALD
• 金额: $ 19.9万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9926735
• 关键词: Address; Affect; Age; Alaska Native; All of Us Research Program; Alzheimer' s Disease; Alzheimer' s disease risk; American; American Indians; Area; Arizona; Attitude; Biological; Blood; Clinical; Clinical Management; Clinical Treatment; Cognition; Communication; Communication Barriers; Communities; Comprehension; Consent; Data; Dementia; Diagnosis; Disease; Education; Educational workshop; Effectiveness; Enrollment; Environmental Risk Factor; Evaluation; Funding; Future; General Population; Health; Health Policy; Health behavior; Imagery; Individual; Influentials; Intervention; Joints; Knowledge; Link; Longitudinal Studies; Measures; Methods; Modality; Music; National Institute on Aging; Native-Born; Oral; Outcome; Pamphlets; Participant; Patient Recruitments; Patient-Focused Outcomes; Patients; Population; Precision Medicine Initiative; Prevalence; Preventive Intervention; Preventive treatment; Publishing; Qualitative Methods; Randomized; Randomized Controlled Trials; Recording of previous events; Research; Research Personnel; Research Priority; Resources; Risk; Sampling; Shapes; Site; Specimen; Subgroup; Testing; United States National Institutes of Health; Universities; Urine; Visual Aid; Voice; Work; academic standard; base; cancer therapy; cohort; digital; ethnic minority population; experience; genomic biomarker; health care service organization; health disparity; health literacy; human old age (65+); improved; informant; innovation; interest; lifestyle data; member; personal narratives; population based; pragmatic trial; precision medicine; preference; prevent; primary outcome; programs; racial minority; recruit; repository; rurality; sex; side effect; standard care; stem; success; willingness

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.

摘要 阿尔茨海默病（Alzheimer's disease，AD）是痴呆的一种常见形式，但关于AD的风险和患病率的数据很少 美国印第安人和阿拉斯加原住民（AI/ANs）。精准医学（PM）具有检测和 治疗AD等疾病。PM结合了临床、基因组、生物标志物和环境因素的数据 用健康行为的数据来评估特定疾病的个体风险。它可以最大限度地发挥 个性化的临床管理。然而，没有研究涉及AI/AN的通信偏好 AD或PM研究的教育或招募信息。AI/AN遇到沟通障碍， 研究参与，以及更喜欢视觉辅助工具，以帮助理解和沟通， 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 少数种族和族裔的充分代表性。2016年，NIH资助了8家医疗机构， 召集100万人，他们将提供血液和尿液样本，沿着健康， 环境和生活方式的数据，以人口为基础的储存库PM研究（我们所有的研究 程序）。我们将与一个受资助者合作- 亚利桑那大学/班纳健康-这将招收 10，000名AI/AN-评估在其凤凰城图森临床设施招募AI/AN的方法。AI/AN 线人将帮助创建文化上合适的招聘材料（小册子，数字故事）为广告， PM研究。最后，我们将进行一项实用的随机对照试验，有4,000名AI/AN入组， 我们所有人参加者将收到一份关于AD和PM的标准教育手册， 研究的重要性（对照）或具有相同信息的文化定制的图形丰富的小册子，以及 查看一个数字故事，其中包含AI/AN对AD（干预）的个人叙述。届时将邀请与会者 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，并将他们的所有我们的数据和生物标本链接到他们的AD-PM模块数据。我们的两个主要成果 将完成AD-PM模块并入组AD-PM队列。具体目标是：（1） 评估UAZB计划中AI/AN的招聘策略，并解决可能影响 我们的试验的实施; 2）创建文化定制的AD和PM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队列入组;以及4）确定AD-PM队列的患者水平预测因素 招募，并按年龄，性别， 教育、文化认同和乡村生活。AD-PM队列将成为缓解 AI/AN在AD和PM研究中的代表性明显不足。结果将突出沟通 促进或阻碍AI/AN招募的策略，阐明关于AD和PM的知识差距。