Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
629 participants
INTERVENTIONAL
2023-01-12
2026-06-30
Brief Summary
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Detailed Description
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The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is an National Institute on Aging (NIA)-sponsored Phase III randomized controlled trial (R01AG055426; Multiple Principal Investigators: Lin/Coresh) investigating whether hearing loss treatment versus an aging education control intervention reduces cognitive decline over a 3-year follow-up period. From 2018 to 2019, the investigators recruited 977 adults aged 70-84 years with untreated mild-to-moderate hearing loss who were randomized 1:1 at baseline to receive hearing intervention (HI; best practices hearing services and technologies) versus a successful aging (SA) education control intervention (i.e., one-on-one sessions with a health educator covering topics important for healthy aging). Participants are followed semi-annually at the ACHIEVE field sites (Washington County, Maryland; Jackson, Mississippi; Minneapolis, Minnesota; Forsyth County; North Carolina) with final Year 3 study visits for ACHIEVE participants scheduled from 2021-2022. After the participants Year 3 visit, all participants randomized to the SA education control group will also be offered the hearing intervention. Final Year 3 results from this original trial will indicate whether hearing intervention (versus a successful aging control intervention) reduces cognitive decline over a 3-year interval after randomization.
ACHIEVE BRAIN HEALTH FOLLOW-up STUDY:
The current study will continue following the ACHIEVE cohort for an additional 3 years after the participants Year 3 visit (i.e., total of 6 years) to determine the long-term effects of hearing intervention (i.e., participants randomized to HI at ACHIEVE baseline) versus successful aging/delayed HI control (i.e., participants randomized to SA at ACHIEVE baseline and offered HI after the participants ACHIEVE Year 3 visit) on cognitive, dementia, and brain outcomes. Given that cognitive impairment typically reflects the slow accumulation of pathologic changes, the benefits of hearing intervention in slowing this decline may not be fully appreciable within just 3 years. Therefore, this 6-year follow-up of the cohort will allow the investigators to fully evaluate the longer, cumulative impact of hearing loss treatment on older adults. Such findings will complement the main trial results in 2023 and directly inform clinical and policy decisions around the potential use of hearing interventions to reduce the risk of cognitive decline and Alzheimer's disease and related dementias (ADRD).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hearing intervention (HI) group
Participants in this group were randomized to the hearing intervention (HI) group at ACHIEVE trial baseline and received a best practices hearing rehabilitation treatment program, consisting of fitting with hearing aids and other hearing assistive technologies along with comprehensive, individualized hearing rehabilitation sessions with a study audiologist spaced over the 2-3 months post-fitting designed to provide all the active components of the intervention. Participants also received semi-annual booster sessions with the study audiologist. These participants will continue to receive hearing healthcare from the study audiologist and complete semi-annual sessions for 3 additional years.
Hearing intervention
The hearing intervention is best practices hearing rehabilitation treatment program, consisting of fitting with hearing aids and other hearing assistive technologies along with comprehensive, individualized hearing rehabilitation sessions with a study audiologist spaced over the 2-3 months post-fitting designed to provide all the active components of the intervention. Participants also received semi-annual booster sessions with the study audiologist for 3 years and will continue to receive hearing healthcare from the study audiologist and complete semi-annual sessions for 3 additional years.
Successful aging/Delayed hearing intervention (SA/DHI) group
Participants in this active control group were randomized to the successful aging (SA) group at ACHIEVE trial baseline and received a successful aging health education program, following the protocol and materials developed for the 10 Keys to Healthy Aging program. The program involved individualized sessions with a study health educator to control for staff-participant time and attention between the two groups. Upon completion of the ACHIEVE trial, these participants are offered the best practices hearing rehabilitative treatment program with comprehensive, individualized sessions post-fitting and will receive semi-annual booster sessions with the study audiologist for 3 years.
Successful aging/delayed hearing intervention
The successful aging health education program follows the protocol and materials developed for the 10 Keys to Healthy Aging program. The program involved individualized sessions with a study health educator, with initial sessions spaced over the 2-3 months post-randomization and semi-annual sessions for 3 years. Upon completion of the ACHIEVE trial, these participants are offered the best practices hearing rehabilitative treatment program with comprehensive, individualized sessions post-fitting and will receive semi-annual booster sessions with the study audiologist for 3 years.
Interventions
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Hearing intervention
The hearing intervention is best practices hearing rehabilitation treatment program, consisting of fitting with hearing aids and other hearing assistive technologies along with comprehensive, individualized hearing rehabilitation sessions with a study audiologist spaced over the 2-3 months post-fitting designed to provide all the active components of the intervention. Participants also received semi-annual booster sessions with the study audiologist for 3 years and will continue to receive hearing healthcare from the study audiologist and complete semi-annual sessions for 3 additional years.
Successful aging/delayed hearing intervention
The successful aging health education program follows the protocol and materials developed for the 10 Keys to Healthy Aging program. The program involved individualized sessions with a study health educator, with initial sessions spaced over the 2-3 months post-randomization and semi-annual sessions for 3 years. Upon completion of the ACHIEVE trial, these participants are offered the best practices hearing rehabilitative treatment program with comprehensive, individualized sessions post-fitting and will receive semi-annual booster sessions with the study audiologist for 3 years.
Eligibility Criteria
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Inclusion Criteria
* Agree to participate and are able and willing to comply with study procedures for three years in the follow-up study
* Age 70-84 years
* Community dwelling, fluent English speaker
* Availability of participant in area for study duration
* Adult-onset hearing impairment, defined as four-frequency pure tone average (PTA, 0.5-4 kilohertz (kHz), better ear) ≥ 30 decibels hearing level (dB HL) \& ≤ 70 dB HL
* Speech recognition scores in quiet ≥ 60% in better ear
* Mini-Mental State Exam (MMSE) score ≥ 23 for high school degree or less; ≥ 25 for some college or more
Exclusion Criteria
* Vision impairment (worse than 20/63 on the Minnesota Near Vision Card)
* Self-reported use of a hearing aid in the past 1 year
* Medical contraindication to use of hearing aids (e.g., draining ear)
* Unwilling to wear hearing aids on a daily basis
* Conductive hearing impairment with air-bone gap \> 15 dB (decibels) in two or more contiguous frequencies in both ears
73 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
University of North Carolina
OTHER
University of South Florida
OTHER
University of Minnesota
OTHER
University of Mississippi Medical Center
OTHER
Wake Forest University
OTHER
Mayo Clinic
OTHER
National Institute on Aging (NIA)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Frank R Lin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Josef Coresh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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Johns Hopkins Comstock Center for Public Health Research and Prevention
Hagerstown, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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References
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Gross AL, Power MC, Albert MS, Deal JA, Gottesman RF, Griswold M, Wruck LM, Mosley TH Jr, Coresh J, Sharrett AR, Bandeen-Roche K. Application of Latent Variable Methods to the Study of Cognitive Decline When Tests Change over Time. Epidemiology. 2015 Nov;26(6):878-87. doi: 10.1097/EDE.0000000000000379.
Other Identifiers
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IRB00319430
Identifier Type: -
Identifier Source: org_study_id