技术使用与听力保健干预结局：一项随机临床试验的二次分析

文献信息

中文摘要

重要性： 非处方（OTC）助听器通常依赖数字技术，这可能限制技术使用水平较低的老年人的可及性。由社区卫生工作者（CHW）提供的干预可能有助于克服这些障碍，但基线技术使用情况是否会改变干预疗效尚不清楚。
目的： 评估老年人的基线技术使用情况是否会改变由CHW提供、包含OTC助听设备的听力保健干预对自我感知交流功能的影响。
设计、场所和参与者： 这项二次事后亚组分析使用了HEARS（通过可及研究与解决方案实现听力健康公平）研究的数据，该研究是一项平行分组1:1随机临床试验，设有等待名单对照，于2018年4月至2019年10月期间开展。HEARS从马里兰州巴尔的摩的13个社区场所（包括经济适用独立住房综合体和老年中心）招募了年龄≥60岁、患有未治疗听力损失且自报交流困难的老年人。主要终点在随机化后3个月评估，并额外进行干预后长达12个月的描述性随访。数据分析时间为2023年8月至2026年3月。
干预： 由CHW提供的听力保健干预，包括提供低成本OTC助听设备、设备使用指导以及导航支持，或等待名单对照。
主要结局和测量指标： 主要结局为随机化后3个月时老年听力障碍筛查量表（HHIE-S）评分较基线的变化。若参与者报告近期使用智能手机、电脑或平板电脑、互联网，或电子邮件或短信，则被归类为技术连接型。干预效应采用双重稳健加权最小二乘法估计，并按技术使用情况分层。
结果： 分析纳入151名参与者（平均[SD]年龄76.7[8.0]岁；101名女性[67.8%]），其中108名（71.5%）为技术连接型。随机化后3个月时，与各自对照相比，技术连接型参与者的HHIE-S评分平均下降14.1分（95% CI，-17.6至-9.9），非连接型参与者平均下降12.5分（95% CI，-16.2至-5.2）。两组间治疗效应估计差异为-1.6分（95% CI，-7.8至4.1）。
结论和意义： 这项随机临床试验的二次分析发现，由CHW提供的听力保健干预的估计治疗效应在参与者基线技术使用的各分层间保持一致。这些探索性发现提示，导航支持可能减轻老年人听力保健干预中与技术相关的障碍。
试验注册： ClinicalTrials.gov标识符：NCT03442296。

英文摘要

IMPORTANCE: Over-the-counter (OTC) hearing aids often rely on digital technologies that may limit access for older adults with low technology use. Community health worker (CHW)-delivered interventions may help overcome these barriers, but it is unclear whether baseline technology usage modifies intervention efficacy.
OBJECTIVE: To evaluate whether an older adult's baseline technology use modifies the effect of a CHW-delivered hearing care intervention incorporating OTC hearing devices on self-perceived communication function.
DESIGN, SETTING, AND PARTICIPANTS: This secondary post hoc subgroup analysis used data from the HEARS (Hearing Health Equity Through Accessible Research & Solutions) study, a parallel-group 1:1 randomized clinical trial with waitlist controls that was conducted between April 2018 and October 2019. HEARS recruited older adults (age ≥ 60 years) with untreated hearing loss and self-reported communication difficulties from 13 community sites, including affordable independent housing complexes and senior centers, in Baltimore, Maryland. The primary end point was assessed at 3 months postrandomization, with additional descriptive follow-up through 12 months postintervention. Data were analyzed from August 2023 to March 2026.
INTERVENTION: A CHW-delivered hearing care intervention that includes the provision of a low-cost OTC hearing device, device orientation, and navigational support or a wait-list control.
MAIN OUTCOMES AND MEASURES: Change from baseline score on the Hearing Handicap Inventory for the Elderly-Screening Version (HHIE-S) at 3 months postrandomization was the primary outcome. Participants were classified as technology-connected if they reported recent use of a smartphone, computer or tablet, the internet, or email or text messaging. Intervention effects were estimated using doubly robust weighted least squares, stratified by technology use.
RESULTS: The analysis comprised 151 participants (mean [SD] age, 76.7 [8.0] years; 101 females [67.8%]), of whom 108 (71.5%) were technology-connected. At 3 months postrandomization, HHIE-S scores decreased by a mean of 14.1 (95% CI, -17.6 to -9.9) points among technology-connected participants and by 12.5 (95% CI, -16.2 to -5.2) points among not-connected participants compared with their respective controls. The estimated difference in treatment effect between groups was -1.6 (95% CI, -7.8 to 4.1) points..
CONCLUSIONS AND RELEVANCE: This secondary analysis of a randomized clinical trial found that the estimated treatment effects of a CHW-delivered hearing care intervention were consistent across strata of participants' baseline technology use. These exploratory findings suggest that navigational support may mitigate technology-related barriers in hearing care interventions for older adults.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03442296.