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: 10164622
• 负责人: DEDRA S BUCHWALD
• 金额: $ 41.74万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10164622
• 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; 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 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+); implementation evaluation; improved; informant; innovation; interest; lifestyle data; member; personal narratives; population based; pragmatic trial; precision medicine; preference; prevent; preventive intervention; 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.

抽象的 阿尔茨海默氏病（AD）是痴呆症的一种常见形式，但几乎没有关于AD风险和患病率的数据 在美洲印第安人和阿拉斯加土著人（AI/ANS）中。精密医学（PM）有可能检测和 治疗诸如AD之类的疾病。 PM结合了有关临床，基因组，生物标志物和环境因素的数据 借助有关健康行为的数据，以评估给定疾病的个人风险。它可以最大化 量身定制的临床管理。但是，没有研究涉及AI/A的偏好 广告或PM研究的教育或招聘信息。 AI/ANS经历了通信障碍 研究参与以及更喜欢有助于理解和沟通的视觉辅助 具有本土传统。 2015年，奥巴马总统宣布了一项2.15亿美元的下午倡议，强调 足够代表种族和少数民族。 2016年，NIH资助了8个医疗组织 组成一百万人组成的人，他们将贡献血液和尿液样本以及健康状况 环境和生活方式数据向基于人群的存储库进行PM研究（我们所有人研究 程序）。我们将与一位受赠人合作 - 亚利桑那大学/旗帜健康 - 将会注册 10,000个AI/ANS - 评估在其凤凰城临床设施中招募AI/ANS的方法。 ai/an 信息将有助于为广告和 PM研究。最后，我们将进行一项务实的随机对照试验，其中4,000个AI/ANS参加 我们所有人队列。参与者将在广告和PM上获得标准的教育手册以及 研究（控制）或具有相同信息的图形富含图形的小册子的重要性 查看一个数字故事，其中包含AI/ANS的个人叙述（干预）。然后将邀请参与者 完成可选的AD-PM模块，以评估广告知识和参加，健康素养，种族 识别和认知。完成后，他们将加入对未来广告和PM感兴趣的其他AI/ANS 研究，并将他们所有的数据和生物测量与AD-PM模块数据联系起来。我们的两个主要结果 AD-PM模块和AD-PM队列中的注册将完成。具体目的是：1） 评估UAZB计划中AI/ANS的招聘策略，并解决可能影响的因素 实施我们的审判； 2）在AD和PM上创建具有文化量身定制的材料，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的影响 AD-PM模块和AD-PM队列的注册； 4）确定AD-PM队列的患者级预测指标 注册并评估按年龄，性别， 教育，文化身份和粗糙。 AD-PM队列将代表减轻的独特资源 AI/ANS在AD和PM研究中的代表性不足。结果将突出沟通 促进或阻碍AI/A招募的策略，阐明了有关AD和PM的知识差距。