ACHIEVE Brain Health Follow-Up Study

Last updated: November 13, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Memory Loss

Memory Problems

Hearing Loss

Treatment

Successful aging/delayed hearing intervention

Hearing intervention

Clinical Study ID

NCT05532657
IRB00319430
R01AG076518
  • Ages > 73
  • All Genders

Study Summary

The ACHIEVE Brain Health Follow-Up Study is a 3-year follow-up to the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study to determine the long-term effect of hearing intervention vs. successful aging/delayed hearing intervention on rates of cognitive decline and incident mild cognitive impairment or dementia.

Eligibility Criteria

Inclusion

To be eligible for ACHIEVE-BHFU, participants must meet the following criteria:

  • Eligible for and participated in the ACHIEVE trial (see original criteria below)

  • Agree to participate and are able and willing to comply with study procedures forthree years in the follow-up study

Original ACHIEVE Inclusion Criteria (during 2018-2019 enrollment):

  • 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 forsome college or more

Exclusion

Original ACHIEVE Exclusion Criteria:

  • Reported disability in ≥ 2 activities of daily living (ADLs)

  • 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 morecontiguous frequencies in both ears

Study Design

Total Participants: 629
Treatment Group(s): 2
Primary Treatment: Successful aging/delayed hearing intervention
Phase: 3
Study Start date:
January 12, 2023
Estimated Completion Date:
June 30, 2026

Study Description

ORIGINAL ACHIEVE TRIAL:

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).

Connect with a study center

  • Johns Hopkins Comstock Center for Public Health Research and Prevention

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Wake Forest University

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

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