Improving Hispanic/Latino participation in preclinical Alzheimers disease Trials

提高西班牙裔/拉丁裔对临床前阿尔茨海默病试验的参与

• 批准号: 10675570
• 负责人: Christian R Salazar
• 金额: $ 13.71万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-03 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10675570
• 关键词: Active Learning; Address; Adult; Adverse event; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; Attitude; Behavior Therapy; Behavioral; Belief; Biological Markers; California; Clinical Research; Cognitive; Communities; Data; Decision Making; Dedications; Disparity; Elderly; Enrollment; Ensure; Epidemiologist; Ethnic Origin; Fellowship; Foundations; Funding; Goals; Grant; Health; Health Disparities Research; Healthcare Systems; Hispanic; Hispanic Populations; Individual; Infrastructure; Instruction; Intention; Internet; Intervention; K-Series Research Career Programs; Knowledge; Latino; Latino Population; Leadership; Linguistics; Literature; Mentors; Mentorship; Methods; Minority Recruitment; Modeling; Multicenter Studies; Multicenter Trials; Not Hispanic or Latino; Participant; Persons; Population; Positioning Attribute; Process; Race; Randomized; Recommendation; Registries; Research; Research Personnel; Resources; Safety; Sampling; Science; Scientist; Solid; Surveys; Testing; Training; Treatment Efficacy; Underrepresented Populations; Underserved Population; United States National Institutes of Health; University resources; Work; clinical trial recruitment; cognitive interview; community based research; contextual factors; design; evidence base; experience; health literacy; improved; innovation; insight; intervention mapping; literacy; novel; pilot test; population based; pre-clinical; preclinical trial; randomized, clinical trials; recruit; recruitment science; risk perception; skills; therapy design; treatment effect; willingness

Project Summary Despite longstanding efforts to improve recruitment of minorities into Alzheimer’s Disease and Related Dementias (ADRD) research, US Hispanics/Latinos continue to be severely underrepresented in ADRD randomized clinical trials. Greater representation of Hispanics/Latinos is critical to ensure the safety and efficacy of interventions and the generalizability of results across an increasingly diverse US population. Preclinical AD trials will be essential in the pursuit of improved ADRD therapies and are unique in requiring asymptomatic individuals to undergo biomarker testing and to enroll with a study partner. It is unclear, however, whether these unique requirements pose a specific challenge to the recruitment of Hispanics/Latinos into preclinical AD trials. It is imperative that we discover and test novel interventions to improve recruitment of Hispanics/Latinos to these trials. Given my background as an epidemiologist with a solid foundation in health disparities research, I have the dedication for undertaking this research. Through this K01 Mentored Research Scientist Career Development Award, I propose to receive the necessary training and research experience to address several gaps and become a leader in ADRD recruitment science. My overarching hypothesis is that older Hispanics/Latinos are less willing than their Non-Hispanic (NHW) counterparts to participate in preclinical AD trials, due in part to modifiable behavioral factors amenable to intervention. To test this hypothesis, I propose three specific research aims: (1) First, I will examine differences in willingness to participate in preclinical AD trials between diverse Hispanics/Latinos and Non-Hispanic whites (NHW) from a national population-based sample of 1,800 older adults who respond to a web panel survey. (2) Next, through in-person cognitive interviews, I will identify key behavioral determinants of intention to participation in a sample of 100 local community dwelling older Hispanics/Latinos, with a particular focus on contextual factors, cultural beliefs/values, research literacy, previous experiences with the healthcare system, research attitudes and perceived need/benefit. (3) Lastly, I will use an Intervention Mapping planning approach to systematically develop and pilot test a behavioral intervention that is culturally and linguistically appropriate and designed to improve Hispanic/Latino participation in AD preclinical trials. Findings will provide preliminary data for a large multicenter trial to test the intervention using a randomized approach. To accomplish these aims and my goal of becoming an independent investigator, I propose to engage in extensive ADRD training through didactic instruction, experiential learning and mentorship by the leaders in the field. I will leverage resources from the University of California, Irvine Alzheimer’s Disease Research Center to (a) acquire foundational knowledge of core principles in ADRD research, (b) gain experience in mixed- methods approaches in recruitment science, (c) become proficient in designing behavioral interventions, and (d) develop the leadership skills necessary to conduct multicenter studies and propel my research forward.

项目摘要 尽管长期以来一直在努力改善招募少数民族进入阿尔茨海默病和相关疾病的情况， 痴呆症（ADRD）研究，美国西班牙裔/拉丁裔在ADRD中的代表性仍然严重不足 随机临床试验。西班牙裔/拉丁裔的更多代表性对于确保安全性和有效性至关重要 在日益多样化的美国人口中，干预措施和结果的普遍性。临床前AD 试验将是必不可少的，在追求改善ADRD治疗，是独特的，需要无症状 个体接受生物标志物检测并与研究伙伴一起入组。目前尚不清楚，这些 独特的要求对临床前AD试验招募西班牙裔/拉丁裔美国人提出了具体挑战。 我们必须发现和测试新的干预措施，以改善西班牙裔/拉丁裔的招聘， 审判鉴于我作为一名流行病学家的背景，在健康差异研究方面有着坚实的基础， 致力于这项研究。通过这个K 01指导研究科学家的职业发展 奖，我建议接受必要的培训和研究经验，以解决几个差距，并成为 ADRD招募科学的领导者。我的总体假设是，老年西班牙裔/拉丁裔人不太愿意 比非西班牙裔（NHW）同行参与临床前AD试验，部分原因是可修改的 行为因素易于干预。为了验证这一假设，笔者提出了三个具体的研究目标：（1） 首先，我将研究不同年龄组患者参与临床前AD试验的意愿差异， 西班牙裔/拉丁裔和非西班牙裔白人（NHW）从全国人口为基础的样本1,800老年人 参加网络小组调查的成年人。(2)接下来，通过面对面的认知访谈，我将确定 100名当地社区老年人参与意愿的行为决定因素 西班牙裔/拉丁裔，特别关注背景因素，文化信仰/价值观，研究素养，以前的 与医疗保健系统的经验，研究态度和感知的需求/利益。(3)最后，我将使用一个 干预映射规划方法，系统地开发和试点测试行为干预， 在文化和语言上适当，旨在改善西班牙裔/拉丁裔参与AD临床前治疗 审判研究结果将为一项大型多中心试验提供初步数据，该试验使用随机 approach.为了实现这些目标和我成为一名独立调查员的目标，我建议从事 在广泛的ADRD培训，通过教学指导，体验式学习和导师的领导人， 外地我将利用加州大学欧文阿尔茨海默病研究中心的资源 （a）获得ADRD研究核心原则的基础知识，（B）获得混合- 招聘科学的方法，（c）精通设计行为干预措施，以及（d） 培养领导能力，进行多中心研究，推动我的研究向前发展。