Leeds Institute of Cardiovascular and Metabolic Medicine (LICAMM), University of Leeds, Leeds, UK.
York Trials Unit, Department of Health Sciences, University of York, York, UK.
BMJ Open. 2018 Aug 1;8(7):e021502. doi: 10.1136/bmjopen-2018-021502.
Up to 30% of hearing aids fitted to new adult clients are reported to be of low benefit and used intermittently or not at all. Evidence suggests that additional interventions paired with service-delivery redesign may help improve hearing aid use and benefit. The range of interventions available is limited. In particular, the efficacy of interventions like the Active Communication Education (ACE) programme that focus on improving communication success with hearing-impaired people and significant others, has not previously been assessed. We propose that improved communication outcomes associated with the ACE intervention, lead to an increased perception of hearing aid value and more realistic expectations associated with hearing aid use and ownership, which are reported to be key barriers and facilitators for successful hearing aid use. This study will assess the feasibility of delivering ACE and undertaking a definitive randomised controlled trial to evaluate whether ACE would be a cost-effective and acceptable way of increasing quality of life through improving communication and hearing aid use in a public health service such as the National Health Service.
This will be a randomised controlled, open feasibility trial with embedded economic and process evaluations delivered in audiology departments in two UK cities. We aim to recruit 84 patients (and up to 84 significant others) aged 18 years and over, who report moderate or less than moderate benefit from their new hearing aid. The feasibility of a large-scale study and the acceptability of the ACE intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews.
Ethical approval granted by South East Coast-Surrey Research Ethics Committee (16/LO/2012). Dissemination of results will be via peer-reviewed research publications both online and in print, conference presentations, posters, patient forums and Trust bulletins.
ISRCTN28090877.
据报道，新配给成年患者的助听器中，有 30% 的助听器效果不佳，患者间歇性使用或完全不用。有证据表明，结合服务模式设计进行额外干预可能有助于提高助听器的使用效果和受益。目前可用的干预措施有限。特别是，像积极沟通教育（ACE）计划这样的干预措施的疗效，该计划侧重于提高与听力受损者和重要他人的沟通成功率，尚未得到评估。我们假设 ACE 干预措施与改善沟通结果相关，从而增加对助听器价值的感知，以及与助听器使用和所有权相关的更现实的期望，这些被认为是成功使用助听器的关键障碍和促进因素。本研究将评估 ACE 的可行性，并开展一项确定性随机对照试验，以评估 ACE 是否通过改善沟通和提高助听器使用效果，从而提高生活质量，在国民保健服务等公共卫生服务中是否具有成本效益和可接受性。
这将是一项在英国两个城市的听力科进行的随机对照、开放可行性试验，同时进行嵌入的经济和过程评估。我们的目标是招募 84 名年龄在 18 岁及以上的患者（和多达 84 名重要他人），他们报告从新助听器中获得的受益中度或低于中度。通过招募率、治疗保留率、随访率和定性访谈来衡量大规模研究的可行性和 ACE 干预措施的可接受性。
东南海岸-萨里研究伦理委员会（16/LO/2012）已批准伦理。通过在线和印刷的同行评审研究出版物、会议演讲、海报、患者论坛和信托公告来传播结果。
ISRCTN28090877。
