Howard H Feldman, MD, University of California, San Diego, 9500 Gilman Drive, MC 0949, La Jolla, CA 92037-0949,
J Prev Alzheimers Dis. 2023;10(4):875-885. doi: 10.14283/jpad.2023.65.
BACKGROUND/OBJECTIVES: CAN-THUMBS UP is designed as a comprehensive and innovative fully remote program to 1) develop an interactive and compelling online Brain Health Support Program intervention, with potential to positively influence dementia literacy, self-efficacy and lifestyle risk factors; 2) enroll and retain a community-dwelling Platform Trial Cohort of individuals at risk of dementia who will participate in the intervention; 3) support an open platform trial to test a variety of multidomain interventions that might further benefit individuals at risk of dementia. This manuscript presents the Brain Health Support Program Study protocol.
DESIGN/SETTING: Twelve-month prospective multi-center longitudinal study to evaluate a fully remote web-based educational intervention. Participants will subsequently be part of a Platform Trial Cohort and may be eligible to participate in further dementia prevention clinical trials.
Three hundred fifty older adults who are cognitively unimpaired or have mild cognitive impairment, with at least 1 well established dementia risk factor.
Participants engage in the Brain Health Support Program intervention for 45-weeks and complete pre/post intervention measures. This intervention is designed to convey best available evidence for dementia prevention, consists of 181 chapters within 8 modules that are progressively delivered, and is available online in English and French. The program has been developed as a collaborative effort by investigators with recognized expertise in the program's content areas, along with input from older-adult citizen advisors.
This study utilizes adapted remote assessments with accessible technologies (e.g. videoconferencing, cognitive testing via computer and mobile phone, wearable devices to track physical activity and sleep, self-administered saliva sample collection). The primary outcome is change in dementia literacy, as measured by the Alzheimer's Disease Knowledge Scale. Secondary outcomes include change in self-efficacy; engagement using the online program; user satisfaction ratings; and evaluation of usability and acceptance. Exploratory outcomes include changes in attitudes toward dementia, modifiable risk factors, performance on the Neuropsychological Test Battery, performance on self-administered online cognitive assessments, and levels of physical activity and sleep; success of the national recruitment plan; and the distribution of age adjusted polygenic hazard scores.
This fully remote study provides an accessible approach to research with all study activities being completed in the participants' home environment. This approach may reduce barriers to participation, provide an easier and less demanding participant experience, and reach a broader geography with recruitment from all regions of Canada. CAN-THUMBS UP represents a Canadian contribution to the global World-Wide FINGERS program (alz.org/wwfingers).
背景/目的：CAN-THUMBS UP 是一项全面而创新的全远程项目，旨在：1）开发一个互动且引人入胜的在线大脑健康支持计划干预措施，有潜力积极影响痴呆症知识、自我效能和生活方式风险因素；2）招募和保留一个有痴呆风险的社区居民平台试验队列，这些人将参与干预；3）支持开放平台试验，以测试各种可能使有痴呆风险的个体进一步受益的多领域干预措施。本文介绍了大脑健康支持计划研究方案。
设计/设置：一项为期 12 个月的前瞻性多中心纵向研究，旨在评估一个完全远程的基于网络的教育干预措施。参与者随后将成为平台试验队列的一部分，并可能有资格参加进一步的痴呆症预防临床试验。
350 名认知正常或有轻度认知障碍的老年人，至少有 1 个明确的痴呆症风险因素。
参与者参与大脑健康支持计划干预 45 周，并完成干预前后的测量。该干预措施旨在传达最佳可用的痴呆症预防证据，由 8 个模块中的 181 个章节组成，这些章节是逐步提供的，并且可以在英语和法语的在线版本中使用。该计划是由在该计划的内容领域具有公认专业知识的研究人员以及老年公民顾问共同努力开发的。
本研究利用远程评估方法，使用可访问的技术（例如视频会议、计算机和移动电话上的认知测试、可穿戴设备来跟踪身体活动和睡眠、自我管理的唾液样本采集）。主要结果是痴呆症知识的变化，通过阿尔茨海默病知识量表来衡量。次要结果包括自我效能的变化；在线计划的参与度；用户满意度评分；以及可用性和接受度的评估。探索性结果包括对痴呆症的态度变化、可改变的风险因素、神经心理测试电池的表现、自我管理的在线认知评估的表现、身体活动和睡眠水平；国家招募计划的成功；以及年龄调整后的多基因危险评分的分布。
这项完全远程研究提供了一种可访问的研究方法，所有研究活动都在参与者的家庭环境中完成。这种方法可能会减少参与的障碍，提供更简单、要求更低的参与者体验，并通过从加拿大所有地区招募来覆盖更广泛的地理区域。CAN-THUMBS UP 是加拿大对全球 World-Wide FINGERS 计划（alz.org/wwfingers）的贡献。
