Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial

Jennifer A. Deal1,2,3, Adele M. Goman2,3, Marilyn S. Albert4, Michelle L. Arnold5, Sheila Burgard6, Theresa Chisolm7, David Couper6, Nancy W. Glynn8, Theresa Gmelin9, Kathleen M. Hayden10, Thomas Mosley11, James S. Pankow12, Nicholas Reed2,3, Victoria A. Sanchez13, A. Richey Sharrett1, Sonia D. Thomas14, Josef Coresh1,15,16, Frank R. Lin1,2,3
1Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
2Department of Otolaryngology—Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA
3Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
4Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA
5College of Science and Mathematics, University of South Florida Sarasota - Manatee, Sarasota, FL, USA
6Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA
7Department of Communication Sciences and Disorders, University of South Florida, Tampa, FL, USA
8Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA
9Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA
10Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA
11The MIND Center, University of Mississippi Medical Center, Jackson, MS, USA
12Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA
13Department of Otolaryngology-Head and Neck Surgery, University of South Florida, Tampa, FL, USA
14RTI International, Research Triangle Park, NC, USA
15George W. Comstock Center for Public Health Research and Prevention, Johns Hopkins Bloomberg School of Public Health, Hagerstown, MD, USA
16Department of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA

Tóm tắt

AbstractIntroductionHearing impairment is highly prevalent and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders study is a multicenter randomized controlled trial to determine efficacy of hearing treatment in reducing cognitive decline in older adults. Clinicaltrials.gov Identifier: NCT03243422.MethodsEight hundred fifty participants without dementia aged 70 to 84 years with mild‐to‐moderate hearing impairment recruited from four United States field sites and randomized 1:1 to a best‐practices hearing intervention or health education control. Primary study outcome is 3‐year change in global cognitive function. Secondary outcomes include domain‐specific cognitive decline, incident dementia, brain structural changes on magnetic resonance imaging, health‐related quality of life, physical and social function, and physical activity.ResultsTrial enrollment began January 4, 2018 and is ongoing.DiscussionWhen completed in 2022, Aging and Cognitive Health Evaluation in Elders study should provide definitive evidence of the effect of hearing treatment versus education control on cognitive decline in community‐dwelling older adults with mild‐to‐moderate hearing impairment.

Tài liệu tham khảo

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