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AgingPhase 3ACHIEVE-BHFUNCT05532657

ACHIEVE Brain Health Follow-Up Study

A Phase 3 study testing Hearing intervention and Successful aging/delayed hearing intervention in people with Aging and Cognitive Decline, run by Johns Hopkins University at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 73 years and older
What is being tested?
Hearing intervention and Successful aging/delayed hearing intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
629 participants
Where
4 sitesUnited States
Study dates
12 Jan 2023to 31 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 73 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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 for three 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 for some college or more

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 more contiguous frequencies in both ears

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Johns Hopkins Comstock Center for Public Health Research and Prevention

    Hagerstown, Maryland, 21740

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Minnesota

    Minneapolis, Minnesota, 55415

  • Wake Forest University

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: Long-term Effects of Hearing Intervention on Brain Health in the Aging and Cognitive Health Evaluation in Elders Randomized Study

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.

Read the detailed 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).

Being tested
Hearing intervention, Successful aging/delayed hearing intervention
Medical subject headings
Cognitive Dysfunction, Dementia, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hearing interventionOther

    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 interventionOther

    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.

Study groups in NCT05532657
Study groupRoleWhat they receive
Hearing intervention (HI) groupActive comparatorParticipants 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.
Receives: Other: Hearing intervention
Successful aging/Delayed hearing intervention (SA/DHI) groupActive comparatorParticipants 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.
Receives: Other: Successful aging/delayed hearing intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in global cognition

    Change from original ACHIEVE trial baseline to ACHIEVE-BHFU final visit in global cognition, as assessed using a factor score derived from completion of a neurocognitive testing battery. The ACHIEVE and ACHIEVE Brain Health studies administer a neurocognitive testing battery annually, which includes the following cognitive tests: Delayed Word Recall, Incidental Learning, Logical Memory I and II, Word Fluency, Animal Naming, Boston Naming, Trail Making Test A and B, Digit Span Backwards, and Digit Symbol Substitution. Factor analytic methods use all items from all tests in the battery to generate a single global cognition score.

    Measured: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)

  2. Mild cognitive impairment (MCI) / dementia

    Time until composite outcome of adjudicated diagnosis of mild cognitive impairment (MCI) or dementia over the course of follow-up from original ACHIEVE trial baseline until ACHIEVE-BHFU final visit.

    Measured: 6 years

Secondary outcomes (5)

  1. Change in cognition memory domain

    Change from original ACHIEVE trial baseline to ACHIEVE-BHFU final visit in the cognition memory domain, as assessed using a memory domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the memory domain include Delayed Word Recall, Incidental Learning, and Logical Memory I and II. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall memory score.

    Measured: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)

  2. Change in cognition executive function domain

    Change from original ACHIEVE trial baseline to ACHIEVE-BHFU final visit in the cognition executive function domain, as assessed using an executive function domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the executive function domain include Trail Making Test A and B and Digit Symbol Substitution. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall executive function score.

    Measured: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)

  3. Change in cognition language domain

    Change from original ACHIEVE trial baseline to ACHIEVE-BHFU final visit in the cognition language domain, as assessed using a language domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the language domain include Word Fluency, Animal Naming, and Boston Naming. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic use items from the tests noted to generate a single overall language score.

    Measured: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)

  4. Change in regional brain volumes

    Change in volume (cm^3) of each MRI-defined brain region of interest from ACHIEVE trial baseline to ACHIEVE-BHFU final visit if the participant previously participated in the ACHIEVE-MRI ancillary study, or from ACHIEVE-BHFU baseline visit to ACHIEVE-BHFU final visit if the participant was not previously enrolled in the ACHIEVE-MRI ancillary study.

    Measured: If in ACHIEVE-MRI: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years); if not in ACHIEVE-MRI: ACHIEVE-BHFU Baseline, ACHIEVE-BHFU Year 3 (~2.5 years)

  5. Change in white matter tract integrity

    Change in MRI fractional anisotropy and mean diffusivity in white matter tracts from ACHIEVE trial baseline to ACHIEVE-BHFU final visit if the participant previously participated in the ACHIEVE-MRI ancillary study, or from ACHIEVE-BHFU baseline visit to ACHIEVE-BHFU final visit if the participant was not previously enrolled in the ACHIEVE-MRI ancillary study.

    Measured: If in ACHIEVE-MRI: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years); if not in ACHIEVE-MRI: ACHIEVE-BHFU Baseline, ACHIEVE-BHFU Year 3 (~2.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start12 Jan 2023
  3. Primary completion28 May 2026
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
629 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05532657
Sponsor's protocol ID
IRB00319430
Other IDs
R01AG076518
Acronym
ACHIEVE-BHFU
Status last verified
Jul 2026
First submitted
31 Aug 2022
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The ACHIEVE Data Coordinating Center, in coordination with the Steering Committee and NIH, will prepare a public access data release that complies with prevailing NIH and HIPAA guidelines in place when the study has been completed. Any participant identifying information will be removed.

Publications

  • 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.

    PubMed 26414855

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hearing intervention and Successful aging/delayed hearing intervention in people with Aging and Cognitive Decline, run by Johns Hopkins University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in global cognition (time frame: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05532657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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