The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study.
The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study.
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DOI：
10.1097/aud.0000000000000858
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发表时间：
2020
期刊：
影响因子：
3.7
通讯作者：
Chisolm, Theresa H.
中科院分区：
文献类型：
--
作者：
Sanchez, Victoria A.;Arnold, Michelle L.;Reed, Nicholas S.;Oree, Preyanca H.;Matthews, Courtney R.;Clock Eddins, Ann;Lin, Frank R.;Chisolm, Theresa H.
这项工作描述了一个手动的最佳实践的听力干预老年人参与老年人的老化和认知健康评估（ACHIEVE）随机对照临床试验的发展。临床试验干预措施的手册化对于确保干预逼真度和质量至关重要，尤其是在大型多中心研究中。多中心ACHIEVE随机对照试验旨在评估听力干预对老年人认知能力下降的有效性。我们描述了手动听力干预的发展，通过一个迭代的过程，包括解决实施问题，通过完成可行性研究（ACHIEVE可行性）。根据已发表的手动干预开发建议，使用迭代过程来定义ACHIEVE-听力干预要素并创建初始手册。然后，在“成就”-可行性研究范围内，采用适合于评估与执行有关的问题的一组事前事后设计，进行干预。参与者于2015年5月至2016年4月期间从佛罗里达州坦帕地区招募。入选标准为年龄70-89岁的认知健康成人，伴有对称性轻度至中度感音神经性听力损失。ACHIEVE-可行性研究旨在通过以下方式评估手动听力干预的实施：（1）确认预期结果的改善，包括噪声性能中的辅助言语和疾病特异性自我报告措施的感知;（2）确定参与者是否会遵守干预措施，包括参加会议和使用助听器;以及（3）确定干预会话是否可以在合理的时间范围内递送。在21名合格的参与者和9名沟通伙伴中，对纳入已确定的最佳做法要素的初始手动干预的可行性进行了评估。干预后的预期结果与噪声中的语音性能的结果表明，在辅助条件下显着改善和自我报告的措施，显着减少自我感知的听力障碍。依从性极佳，21名参与者中有20名（95.2%）完成了所有干预治疗，19名（90.4%）返回进行干预后6个月访视。此外，自我报告的助听器依从性>8小时/天，数据记录的平均每日助听器使用时间为7.8小时。在合理的时间范围内完成研究，每次访视的时间范围为27 - 85分钟。通过迭代过程，完善了干预要素，并根据ACHIEVE-可行性研究活动、结果以及临床医生和参与者的非正式反馈修订了随附手册。本文描述的手动干预的开发过程为未来的研究人员提供了指导，他们的目标是在临床试验中检查听力损失治疗方法的有效性。手动ACHIEVE听力干预提供了一个以患者为中心的标准化分步过程，通过使用助听器、其他听力辅助技术、咨询和教育进行全面的听力评估、目标设定和治疗，旨在支持听力损失的自我管理。ACHIEVE-听力干预在实施方面是可行的，可验证预期结果、合规性和合理的时间框架。我们的流程确保ACHIEVE随机对照试验中使用的干预保真度和质量（）。
This work describes the development of a manualized best-practice hearing intervention for older adults participating in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized controlled clinical trial. Manualization of interventions for clinical trials is critical for assuring intervention fidelity and quality, especially in large multi-site studies. The multi-site ACHIEVE randomized controlled trial is designed to assess the efficacy of a hearing intervention on rates of cognitive decline in older adults. We describe the development of the manualized hearing intervention through an iterative process that included addressing implementation questions through the completion of a feasibility study (ACHIEVE-Feasibility). Following published recommendations for manualized intervention development, an iterative process was used to define the ACHIEVE-Hearing Intervention elements and create an initial manual. The intervention was then delivered within the ACHIEVE-Feasibility study using one-group pre-post design appropriate for assessing questions related to implementation. Participants were recruited from the Tampa, Florida area between May 2015 and April 2016. Inclusion criteria were cognitively-healthy adults aged 70–89 with symmetrical mild to moderately-severe sensorineural hearing loss. The ACHIEVE-Feasibility study sought to assess the implementation of the manualized hearing intervention by: (1) confirming improvement in expected outcomes were achieved including aided speech in noise performance and perception of disease-specific self-report measures; (2) determining whether the participants would comply with the intervention including session attendance and use of hearing aids; and, (3) determining whether the intervention sessions could be delivered within a reasonable timeframe. The initial manualized intervention that incorporated the identified best-practice elements was evaluated for feasibility among 21 eligible participants and 9 communication partners. Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap. Compliance was excellent, with 20 of the 21 participants (95.2%) completing all intervention sessions, and 19 (90.4%) returning for the 6-month post-intervention visit. Furthermore, self-reported hearing aid compliance was >8 hrs/day, and the average daily hearing aid use from datalogging was 7.8 hours. Study completion was delivered in a reasonable timeframe with visits ranging from 27 – 85 minutes per visit. Through an iterative process, the intervention elements were refined, and the accompanying manual was revised based on the ACHIEVE-Feasibility study activities, results, and clinician and participant informal feedback. The processes for the development of a manualized intervention described here provide guidance for future researchers who aim to examine the efficacy of approaches for the treatment of hearing loss in a clinical trial. The manualized ACHIEVE-Hearing Intervention provides a patient-centered, yet standardized, step-by-step process for comprehensive audiological assessment, goal setting, and treatment through the use of hearing aids, other hearing assistive technologies, counseling and education aimed at supporting self-management of hearing loss. The ACHIEVE-Hearing Intervention is feasible in terms of implementation with respect to verified expected outcomes, compliance, and reasonable timeframe delivery. Our processes assure intervention fidelity and quality for use in the ACHIEVE randomized controlled trial ().