Reed Nicholas S, Gravens-Mueller Lisa, Huang Alison R, Goman Adele M, Mitchell Christine M, Arnold Michelle L, Bolton Spencer, Burgard Sheila, Chisolm Theresa H, Couper David, Deal Jennifer A, Evans Joshua, Faucette Sarah, Glynn Nancy W, Gmelin Theresa, Hayden Kathleen M, Miller Elizabeth, Minotti Melissa, Mosley Thomas, Naylor Stacee, Pankow James S, Pike James Russell, Sanchez Victoria A, Schrack Jennifer A, Coresh Josef, Lin Frank R
Department of Epidemiology Johns Hopkins Bloomberg School of Public Health Baltimore Maryland USA.
Cochlear Center for Hearing and Public Health Johns Hopkins Bloomberg School of Public Health Baltimore Maryland USA.
Alzheimers Dement (N Y). 2024 Feb 14;10(1):e12453. doi: 10.1002/trc2.12453. eCollection 2024 Jan-Mar.
Hearing loss is highly prevalent among older adults and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is a multicenter randomized control trial (partially nested within the infrastructure of an observational cohort study, the Atherosclerosis Risk in Communities [ARIC] study) to determine the efficacy of best-practice hearing treatment to reduce cognitive decline over 3 years. The goal of this paper is to describe the recruitment process and baseline results.
Multiple strategies were used to recruit community-dwelling 70-84-year-old participants with adult-onset hearing loss who were free of substantial cognitive impairment from the parent ARIC study and de novo from the surrounding communities into the trial. Participants completed telephone screening, an in-person hearing, vision, and cognitive screening, and a comprehensive hearing assessment to determine eligibility.
Over a 24-month period, 3004 telephone screenings resulted in 2344 in-person hearing, vision, and cognition screenings and 1294 comprehensive hearing screenings. Among 1102 eligible, 977 were randomized into the trial (median age = 76.4 years; 53.5% female; 87.8% White; 53.3% held a Bachelor's degree or higher). Participants recruited through the ARIC study were recruited much earlier and were less likely to report hearing loss interfered with their quality of life relative to participants recruited de novo from the community. Minor differences in baseline hearing or health characteristics were found by recruitment route (i.e., ARIC study or de novo) and by study site.
The ACHIEVE study successfully completed enrollment over 2 years that met originally projected rates of recruitment. Substantial operational and scientific efficiencies during study startup were achieved through embedding this trial within the infrastructure of a longstanding and well-established observational study.
The ACHIEVE study tests the effect of hearing intervention on cognitive decline.The study is partially nested within an existing cohort study.Over 2 years, 977 participants recruited and enrolled.Eligibility assessed by telephone and in-person for hearing, vision, and cognitive screening.The ACHIEVE study findings will have significant public health implications.
听力损失在老年人中极为普遍,且与认知能力下降独立相关。老年人衰老与认知健康评估(ACHIEVE)研究是一项多中心随机对照试验(部分嵌套于一项观察性队列研究——社区动脉粥样硬化风险(ARIC)研究的框架内),旨在确定最佳听力治疗方法在3年内减少认知能力下降的疗效。本文的目的是描述招募过程和基线结果。
采用多种策略招募社区居住的70 - 84岁成年后出现听力损失且无严重认知障碍的参与者,这些参与者一部分来自母本ARIC研究,另一部分是从周边社区新招募的。参与者完成电话筛查、面对面的听力、视力和认知筛查,以及全面的听力评估以确定是否符合条件。
在24个月期间,3004次电话筛查导致2344次面对面的听力、视力和认知筛查以及1294次全面听力筛查。在1102名符合条件者中,977名被随机纳入试验(中位年龄 = 76.4岁;53.5%为女性;87.8%为白人;53.对于从社区新招募的参与者。通过招募途径(即ARIC研究或新招募)和研究地点发现基线听力或健康特征存在细微差异。
ACHIEVE研究在2年内成功完成招募,达到了最初预计的招募率。通过将该试验嵌入一项长期且成熟的观察性研究的框架内,在研究启动期间实现了显著的运营和科学效率。
ACHIEVE研究测试听力干预对认知能力下降的影响。该研究部分嵌套于一项现有的队列研究中。在2年多时间里,招募并纳入了977名参与者。通过电话和面对面方式评估听力、视力和认知筛查的资格。ACHIEVE研究结果将具有重大的公共卫生意义。 3%拥有学士学位或更高学历)。与从ARIC研究招募的参与者相比,从社区新招募的参与者报告听力损失对其生活质量造成干扰的可能性更小。通过招募途径(即ARIC研究或新招募)和研究地点发现基线听力或健康特征存在细微差异。
ACHIEVE研究在2年内成功完成招募,达到了最初预计的招募率。通过将该试验嵌入一项长期且成熟的观察性研究的框架内,在研究启动期间实现了显著的运营和科学效率。
ACHIEVE研究测试听力干预对认知能力下降的影响。该研究部分嵌套于一项现有的队列研究中。在2年多时间里,招募并纳入了977名参与者。通过电话和面对面方式评估听力、视力和认知筛查的资格。ACHIEVE研究结果将具有重大的公共卫生意义。