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: 10183718
• 负责人: FRANK R LIN
• 金额: $ 70.31万
• 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/10183718
• 关键词: Adult; Age; Aging; Area; Audiology; COVID-19 pandemic; Caring; Chronic; Clinic; Clinical; Cognitive; Cognitive aging; 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; Lead; 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; base; 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.

项目摘要 听力损失是慢性病在三分之二> 70年的成年人中普遍存在，可能是一个潜在的 包括痴呆在内的不良健康结果的可修改风险因素。但是，吸收和持续使用 成人的助听器很低，<20％的老年人有听力损失报告使用，其中最多30-3％ 随着时间的流逝，有40％可能停止使用助听器。这些限制可能部分源于 当前基于诊所的访问中听力医疗保健（HHC）的最佳实践模型，需要多个面对面 听力学家与所有正在进行的技术和自我管理支持服务的患者之间的会议。 将异步和同步远程医疗纳入HHC以补充基于诊所的访问 允许常规的沟通挑战，助听器技术问题和强化的沟通挑战故障排除 自我管理支持策略。确定是否合并听力远程医疗的HHC模型 改善长期助听器使用和其他以患者为中心的结果指标对 未来的临床护理标准和正在进行的医疗保险立法法案与HHC覆盖范围有关。我们的 研究人员的跨学科财团有一个奇异的机会来评估 长期助听器使用和其他成果的远程医疗学模型 现有的助听器用户的多样化，居住在社区的老年人。在持续的衰老和认知 长老（成就）随机试验的健康评估，我们招募了977名未经治疗的70-84岁的成年人 从2018年1月到2019年10月的轻度到中度听力损失。 干预（即基于常规诊所的听力服务和技术的交付）与成功 老化的教育控制干预措施。现在，随后的参与者在随后的三年内被遵循 该NIA资助的多站点试验（R01AG055426）的目标是四个实现现场站点，是确定是否是否 听力损失治疗与老龄化的教育控制干预措施减少了认知能力下降。从2021年开始 2022年，随着听力干预组的参与者（n = 490）完成其预先指定的三年 在《成就试验》中，我们建议招募这些现有的助听器用户，并将其随机招募 接收持续的基于常规诊所的助听器服务或一个模型 结合远程医疗。随机化后1年，主要结果（助听器使用时间）将是 两组之间形成鲜明对比，然后，常规HHC组的参与者将交叉，然后 还可以接收远程医疗HHC。所有参与者将在随机化后2年继续遵循。目标1： 比较远程医疗与常规HHC交付模型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。目标2：比较远程医疗的效果与常规HHC交付模型对 随机化后1年，社会，心理，身体和认知功能的次要结果。