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

ACHIEVE 研究中远程医疗与传统听力保健服务的随机试验

• 批准号: 10626871
• 负责人: FRANK R LIN
• 金额: $ 61.39万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10626871
• 关键词: Adult; Age; Aging; Area; Audiology; COVID-19 pandemic; Caring; Chronic; Clinic; Clinical; Cognitive; Communication; Communities; Complement; Congresses; Control Locus; County; Dementia; Education; Elderly; Evaluation; Follow-Up Studies; Funding; Future; Goals; Health; Health Educators; Healthcare; Hearing; Hearing Aids; Hour; Impaired cognition; Individual; Intervention; Investments; Measures; Medicare; Mental Health; Modeling; Outcome; Outcome Measure; Participant; Patient-Focused Outcomes; Patients; Persons; Physical Function; Policies; Provider; Psychological reinforcement; Randomized; Reporting; Research Personnel; Resources; Risk Factors; Role; Sampling; Self Efficacy; Self Management; Service delivery model; Services; Site; Social Functioning; Specific qualifier value; Technology; Time; Transportation; Visit; Washington; arm; care delivery; care systems; clinical care; cognitive function; cohort; efficacy trial; follow-up; functional outcomes; group intervention; health care model; healthy aging; hearing impairment; hearing loss treatment; improved; mental function; modifiable risk; multi-site trial; patient oriented; post intervention; primary outcome; racial diversity; randomized trial; recruit; secondary outcome; stem; telehealth; uptake

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.

项目概要 听力损失是一种慢性疾病，在 70 岁以上的成年人中普遍存在，并且可能是一种潜在的疾病 包括痴呆症在内的不良健康结果的可改变风险因素。然而，吸收和持续使用 成人使用助听器的比例较低，有听力损失的老年人报告使用助听器的比例低于 20%，其中高达 30- 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 当前听力保健 (HHC) 的最佳实践模式是基于诊所的就诊，需要多次亲自到场 听力学家和患者之间的会议，以获取所有持续的技术和自我管理支持服务。 将异步和同步远程医疗纳入 HHC 以补充基于诊所的就诊将 允许对沟通挑战、助听器技术问题和强化进行日常故障排除 自我管理支持策略。确定 HHC 模型是否包含听力学远程医疗 改善长期助听器的使用和其他以患者为中心的结果测量对 未来的临床护理标准和正在进行的与 HHC 覆盖范围相关的 Medicare 立法法案。我们的 跨学科研究人员联盟有一个独特的机会来评估一个项目的潜在好处 关于长期助听器使用和一大群种族群体的其他结果的远程医疗听力学模型 现有助听器使用者的多元化社区老年人。在正在进行的老龄化与认知 老年人健康评估 (ACHIEVE) 随机试验，我们招募了 977 名年龄在 70-84 岁且未经治疗的成年人 2018 年 1 月至 2019 年 10 月期间有轻度至中度听力损失的患者，按照 1:1 的比例随机分配到听证会 干预（即传统的基于临床的听力服务和技术提供）与成功的干预 老龄化教育控制干预。参与者在随机分组后被跟踪 3 年 四个 ACHIEVE 现场试验，这项由 NIA 资助的多试验点试验 (R01AG055426) 的目标是确定是否 听力损失治疗与老龄化教育控制干预相比可以减少认知能力下降。 2021年- 2022 年，听力干预组的参与者 (n=490) 完成预先指定的三年 在 ACHIEVE 试验的后续阶段，我们建议招募这些现有的助听器用户并将他们随机分组 接受持续传统的基于诊所的听力保健服务或模式 纳入远程医疗。随机分组后 1 年，主要结果（助听器使用时间）将是 在两组之间进行对比，然后传统 HHC 组的参与者将交叉并 还接受远程医疗 HHC。所有参与者将在随机分组后继续接受随访 2 年。目标 1： 比较远程医疗与传统 HHC 交付模式对助听器使用时间的影响 （主要结果）以及术后 1 年其他以患者为中心的听力和沟通结果 随机化。目标 2：比较远程医疗与传统 HHC 服务模式的效果 随机化后一年的社会、心理、身体和认知功能的次要结果。