Randomized Trial of Telehealth vs Conventional Hearing Care Delivery in the ACHIEVE Study

项目总结 听力损失是一种慢性疾病，在三分之二的70岁成年人中普遍存在，可能是一种潜在的 包括痴呆症在内的不良健康后果的可改变的风险因素。然而，吸收和持续使用 成年人的助听器很少，据报道，有听力损失的老年人中有20%使用助听器，其中高达30%的人使用助听器。 40%的人可能会随着时间的推移停止使用助听器。这些限制可能部分源于对 当前需要多次面对面就诊的听力保健(HHC)最佳实践模式 听力学专家和患者之间的会议，以获得所有持续的技术和自我管理支持服务。 将异步和同步远程保健纳入HHC以补充以诊所为基础的访问将 允许对通信难题、助听器技术问题和加固进行常规故障排除 自我管理支持策略。确定包含听觉远程健康的HHC模型 改善长期助听器的使用和其他以患者为中心的结果衡量标准直接影响 未来的临床护理标准和正在进行的与HHC覆盖有关的医疗保险立法法案。我们的 跨学科的调查人员联盟有一个独特的机会来评估 关于长期使用助听器和其他结果的远程健康听力学模型在一大群种族- 居住在社区的多元化老年人，他们现在是助听器用户。在正在进行的老龄化与认知 老年人健康评估(ACENTE)随机试验，我们招募了977名年龄在70-84岁之间的未接受治疗的成年人 2018年1月至2019年10月轻中度听力损失患者随机1：1参加听证会 干预(即以传统诊所为基础的听力服务和技术的提供)与成功的 老龄化教育控制干预。参与者现在接受为期3年的随机化后调查 四个实现现场，这项由NIA资助的多站点试验(R01AG055426)的目标是确定 听力损失治疗与老龄化教育控制干预相比，减少了认知能力的下降。从2021年起- 2022年，作为听力干预组(n=490)的参与者，完成他们预先指定的三年 在AQUILE试验中，我们建议招募这些现有的助听器用户，并将他们随机分配到 接受继续以传统诊所为基础的听力护理服务，或采用 整合了远程医疗。在随机化后1年，主要结果(助听器使用时间)将为 在两组之间形成对比，传统HHC组的参与者随后将交叉并 还可以接受远程健康HHC。所有参与者在随机化后将继续接受为期2年的跟踪调查。目标1： 比较远程保健和传统HHC交付模式对助听器使用时间的影响 (主要结果)和其他以患者为中心的听力和沟通结果 随机化。目的2：比较远程医疗和传统HHC服务模式对以下方面的影响 随机化后1年的社会、心理、身体和认知功能的次要结果。

PROJECT SUMMARY Hearing loss is a chronic condition prevalent in two-thirds of adults >70 years and may be a potentially modifiable risk factor for adverse health outcomes including dementia. However, uptake and sustained use of hearing aids in adults is low, with <20% of older adults with hearing loss reporting use, among whom up to 30- 40% may discontinue hearing aid use over time. These limitations may stem in part from the reliance of the current best-practice model of hearing healthcare (HHC) on clinic-based visits that requires multiple in-person sessions between an audiologist and a patient for all ongoing technical and self-management support services. Incorporation of asynchronous and synchronous telehealth into HHC to complement clinic-based visits would allow for routine troubleshooting of communication challenges, hearing aid technical issues, and reinforcement of self-management support strategies. Determining if a HHC model that incorporates audiological telehealth improves long-term hearing aid use and other patient-centered outcome measures has direct implications for both future clinical care standards and ongoing Medicare legislative bills pertaining to HHC coverage. Our interdisciplinary consortium of investigators has a singular opportunity to evaluate the potential benefits of a telehealth audiology model on long-term hearing aid use and other outcomes in a large cohort of racially- diverse, community-dwelling older adults who are existing hearing aid users. In the ongoing Aging & Cognitive Health Evaluation in Elders (ACHIEVE) randomized trial, we recruited 977 adults ages 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October 2019 who were randomized 1:1 to a hearing intervention (i.e., conventional clinic-based delivery of hearing services and technologies) versus a successful aging education control intervention. Participants are now being followed for 3 years post-randomization at the four ACHIEVE field sites, and the goal of this NIA-funded multisite trial (R01AG055426) is to determine if hearing loss treatment versus an aging education control intervention reduces cognitive decline. From 2021- 2022, as participants in the hearing intervention group (n=490) complete their pre-specified three years of follow-up in the ACHIEVE trial, we propose to recruit these existing hearing aid users and randomize them to receive either continued conventional clinic-based delivery of hearing care services or a model that incorporates telehealth. At 1 year post-randomization, the primary outcome (hours of hearing aid use) will be contrasted between the two groups, and participants in the conventional HHC arm will then cross-over and also receive telehealth HHC. All participants will continue to be followed for 2 years post-randomization. Aim 1: To compare the effect of the telehealth versus conventional HHC delivery model on hours of hearing aid use (primary outcome) and other patient-centered hearing and communication outcomes at 1 year post- randomization. Aim 2: To compare the effect of the telehealth versus the conventional HHC delivery model on secondary outcomes of social, mental, physical, and cognitive functioning at 1 year post-randomization.