Addressing Hearing Loss as a Common Unmet Contributor to Neuropsychiatric Symptoms

解决听力损失作为神经精神症状的常见未得到解决的原因

• 批准号: 10417874
• 负责人: CARRIE L NIEMAN
• 金额: $ 81.83万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-15 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10417874
• 关键词: Address; Admission activity; Adult; Adverse event; Age; Agitation; Alzheimer' s Disease; Alzheimer' s disease related dementia; Ambulatory Care; Attenuated; Behavior Therapy; Caring; Characteristics; Clinic; Clinical; Communication; Communication impairment; Consultations; Control Groups; Dementia; Devices; Disease; Disease Progression; Distress; Elderly; Elements; Ensure; Environmental Risk Factor; Equipment and supply inventories; Etiology; Exposure to; Foundations; Goals; Health; Hearing; Hearing Aids; Hearing Tests; Heterogeneity; High Prevalence; Home; Impaired cognition; Individual; Institution; Intervention; Interview; Knowledge; Link; Maintenance; Measures; Mental Depression; Methodology; Methods; Modeling; Nature; Nursing Homes; Outcome; Outcome Measure; Outpatients; Patient Care; Patients; Perception; Personal Satisfaction; Pharmaceutical Preparations; Pilot Projects; Presbycusis; Prevalence; Process; Protocols documentation; Public Health; Quality of life; Questionnaires; Randomized Controlled Trials; Research; Role; Safety; Series; Severities; Sleep disturbances; Specific qualifier value; Structure; Surveys; Symptoms; Target Populations; Technology; Testing; Therapeutic; Time; Translating; Waiting Lists; Work; base; cohort; comorbidity; cost; dementia care; efficacy trial; experience; functional decline; hearing impairment; holistic approach; human old age (65+); implementation barriers; improved; innovation; insight; intervention refinement; mild cognitive impairment; neuropsychiatric symptom; neuropsychiatry; post intervention; primary outcome; racial and ethnic; recruit; reduce symptoms; responders and non-responders; response; socioeconomics; symptom management; tertiary prevention; theories; therapy design

PROJECT SUMMARY As the number of adults age 65 and older continue to increase, the prevalence of Alzheimer’s disease and other related dementias (ADRD) is also expected to increase in the U.S. Neuropsychiatric symptoms (NPS) such as agitation, apathy, depression, and sleep disturbance are highly prevalent in patients with ADRD, with up to 97% of the individuals suffering at least one NPS over the disease course. NPS requires considerable management and time by care partners, and are associated with rapid cognitive and functional decline, worse quality of life, greater care partner burden, and earlier nursing home admissions. Although nonpharmacological intervention for NPS is recommended, psychotropic medications continue to be widely prescribed, resulting in adverse events. Similar to ADRD, the prevalence of hearing loss increases with age. However, hearing care as tertiary prevention for older adults who have already developed cognitive impairment has largely been ignored. MPIs and the Co-Is of the current proposal have been working together for many years, demonstrating that i) there is a high prevalence of hearing loss among indiviudals with mild cognitive impairment (MCI) and ADRD, ii) increasing severity of hearing loss is associated with greater number of NPS and NPS severity, and that iii) a user-centered hearing care intervention that utilizes emerging over-the-counter (OTC) hearing technology may ameliorate NPS. The current proposal is based upon a prior NIA Stage 1b trial that involved an initial pilot study of a hearing care intervention that utilized OTC hearing devices and was delivered in an outpatient setting. The proposed study returns to Stage 1a and 1b to refine and test the preliminary efficacy of a revised hearing care intervention strategy that targets NPS and examines the underlying mechanism(s) of action. Aim 1 seeks to refine the hearing care intervention through a Stage 1a study that involves consultation with experts and end-users to develop a revised intervention protocol that integrates the latest evidence-informed approaches to NPS along with alignment with theoretical frameworks, consideration of implementation challenges encountered in the initial pilot study, and the ability to deliver the intervention in various settings, including the home. Aim 2 will then assess the preliminary efficacy of the revised hearing care intervention through a larger Stage 1b randomized controlled trial, which will allow for greater rigor in assessing the intervention than prior work. Aim 3 will employ a mixed methods approach to characterize response heterogeneity and underlying mechanism(s) of action. The proposed study embraces the iterative and multidirectional nature of the NIA Stage Model with the goal of developing impactful behavioral interventions that reach the maximum level of potency and potentially implementable to the maximum number of older adults. This proposal builds critical foundational knowledge regarding the role of hearing care as an integral component of managing NPS. These findings will directly translate to a larger Stage 2/3 efficacy trial.

项目概要 随着 65 岁及以上成年人数量持续增加，阿尔茨海默病和 其他相关痴呆症 (ADRD) 预计也会在美国增加 神经精神症状 (NPS) ADRD 患者中普遍存在烦躁、冷漠、抑郁和睡眠障碍等症状， 高达 97% 的个体在病程中至少患有一种 NPS。 NPS 需要大量 护理伙伴的管理和时间，并且与认知和功能的快速下降有关，更糟的是 生活质量、更大的护理伙伴负担以及更早入住疗养院。虽然非药理 建议对 NPS 进行干预，精神药物继续广泛使用，导致 不良事件。与 ADRD 类似，听力损失的患病率随着年龄的增长而增加。然而，听力保健作为 对已经出现认知障碍的老年人的三级预防在很大程度上被忽视。 MPI 和当前提案的 Co-Is 已经合作多年，表明 i) 患有轻度认知障碍 (MCI) 和 ADRD 的人听力损失的患病率很高， ii) 听力损失严重程度的增加与 NPS 数量和 NPS 严重程度的增加相关，并且 iii) 利用新兴的非处方 (OTC) 听力技术以用户为中心的听力保健干预措施可能会 改善NPS。当前的提案基于之前的 NIA Stage 1b 试验，其中涉及初始试点 使用 OTC 听力设备并在门诊进行的听力护理干预研究 环境。拟议的研究返回到第 1a 和 1b 阶段，以完善和测试修订后的初步效果 针对 NPS 并检查潜在作用机制的听力保健干预策略。目的 1 寻求通过涉及专家咨询的 1a 阶段研究来完善听力保健干预措施 和最终用户制定修订后的干预协议，其中整合了最新的证据知情的 NPS 方法以及与理论框架的一致性，考虑实施 初步试点研究中遇到的挑战，以及在各种环境下提供干预的能力， 包括家。目标 2 将评估修订后的听力保健干预措施的初步效果 通过更大规模的 1b 阶段随机对照试验，这将允许更严格地评估 干预比之前的工作。目标 3 将采用混合方法来表征响应 异质性和潜在的作用机制。拟议的研究包括迭代和 NIA 阶段模型的多向性，旨在制定有效的行为干预措施 达到最大效力水平，并可能对最大数量的老年人实施 成年人。该提案建立了关于听力保健作为一个整体的作用的关键基础知识 管理 NPS 的组成部分。这些发现将直接转化为更大规模的 2/3 阶段疗效试验。