Wetmore John B, Rodriguez Sophia, Diaz Caro Daniela, Cabán María, Uhlmann Wendy, Goldman Jill, Leu Cheng-Shiun, Godinez Jonathan D, Camarillo Itzel A, Ferber Rebecca, Blasco Drew, Lantigua Rafael A, Abraído-Lanza Ana, Chung Wendy K, Roberts J Scott, Siegel Karolynn, Ottman Ruth
Gertrude H. Sergievsky Center Columbia University Irving Medical Center New York New York USA.
Department of Epidemiology Columbia University Mailman School of Public Health New York New York USA.
Alzheimers Dement (N Y). 2024 Dec 2;10(4):e70016. doi: 10.1002/trc2.70016. eCollection 2024 Oct-Dec.
The (IDEAL) Study is a randomized clinical trial investigating the psychosocial, behavioral, and cognitive impacts of apolipoprotein E () genotype disclosure for late-onset Alzheimer's disease (AD) among Latinos.
We used address-based sampling to recruit English- and Spanish-speaking Latinos aged 40-64 living in northern Manhattan for a community-based Baseline Survey about their knowledge and opinions about AD. Participants eligible for the clinical trial were invited to complete an Introductory Session, including AD and genetics education and informed consent, before undergoing genotyping for . Participants were then randomized to learn their risk of AD by age 85 (range: 21%-55%) based on either Latino ethnicity and family history alone, or the same factors and their genotype. Risk information is provided in a semi-structured genetic counseling session. Psychological impacts, health-related behavioral changes, and cognitive performance are evaluated 6 weeks, 9 months, and 15 months later via surveys and qualitative interviews. To promote cultural competence, study materials were developed by a multidisciplinary team including bilingual and bicultural staff, Latinx content experts, and genetic counselors.
We sent invitations to 91,433 households; 5542 (6.1%) responded, 2120 completed the Baseline Survey (78.5% online; 21.5% via computer-assisted telephone interview), and 2087 were deemed eligible, yielding a response rate of 2.3%. Many participants expressed appreciation for the opportunity to contribute to AD research. We randomized 374 participants for the clinical trial.
We describe the study design, recruitment and retention strategies, and interventions employed in the IDEAL Study. Our design provides a framework for future studies using rigorous mixed methods. Our findings may facilitate the development of culturally-sensitive educational materials about AD and genetic testing, as well as genetic counseling protocols, to improve coping and adjustment in response to receiving risk information.
The (IDEAL) Study investigates apolipoprotein E () genotype disclosure among Latinos using mixed methods.We recruited adults 40-64 years of age without Alzheimer's disease (AD) for a community-based survey and randomized trial.Trial participants receives AD risk estimates with or without genotypes.Psychosocial, behavioral, and cognitive impacts are assessed over 15 months.Findings may inform AD educational materials and genetic counseling protocols.
理想（IDEAL）研究是一项随机临床试验，旨在调查载脂蛋白E（APOE）基因分型披露对拉丁裔迟发性阿尔茨海默病（AD）患者心理社会、行为和认知方面的影响。
我们采用基于地址的抽样方法，招募居住在曼哈顿北部、年龄在40 - 64岁之间、说英语和西班牙语的拉丁裔，进行一项基于社区的基线调查，了解他们对AD的知识和看法。符合临床试验条件的参与者在进行APOE基因分型之前，被邀请参加一个介绍性环节，包括AD和遗传学教育以及知情同意。然后，参与者被随机分组，根据单独的拉丁裔种族和家族史，或相同因素及其APOE基因型，了解他们到85岁时患AD的风险（范围：21% - 55%）。风险信息在一个半结构化的遗传咨询环节中提供。在6周、9个月和15个月后，通过调查和定性访谈评估心理影响、与健康相关的行为变化和认知表现。为提高文化胜任力，研究材料由一个多学科团队开发，该团队包括双语和双文化工作人员、拉丁裔内容专家和遗传咨询师。
我们向91433户家庭发出邀请；5542户（6.1%）回复，2120户完成了基线调查（78.5%通过在线方式；21.5%通过计算机辅助电话访谈），2087户被认为符合条件，回复率为2.3%。许多参与者对有机会为AD研究做出贡献表示感激。我们将374名参与者随机分配到临床试验中。
我们描述了理想（IDEAL）研究的研究设计、招募和保留策略以及所采用的干预措施。我们的设计为未来使用严格混合方法的研究提供了一个框架。我们的研究结果可能有助于开发关于AD和基因检测的文化敏感型教育材料，以及遗传咨询方案，以改善在收到风险信息后的应对和调整。
理想（IDEAL）研究采用混合方法调查拉丁裔中的载脂蛋白E（APOE）基因分型披露情况。我们招募了40 - 64岁无阿尔茨海默病（AD）的成年人进行基于社区的调查和随机试验。试验参与者接受有或无APOE基因型的AD风险评估。在15个月内评估心理社会、行为和认知影响。研究结果可能为AD教育材料和遗传咨询方案提供信息。
