ACHIEVE Brain Health Follow-Up Study
ACHIEVE-BHFU
Long-term Effects of Hearing Intervention on Brain Health in the Aging and Cognitive Health Evaluation in Elders Randomized Study
2 other identifiers
interventional
629
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2023
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedStudy Start
First participant enrolled
January 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
November 10, 2025
November 1, 2025
3.5 years
August 31, 2022
November 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)
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.
6 years
Secondary Outcomes (5)
Change in cognition memory domain
ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)
Change in cognition executive function domain
ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)
Change in cognition language domain
ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)
Change in regional brain volumes
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)
Change in white matter tract integrity
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)
Study Arms (2)
Hearing intervention (HI) group
ACTIVE 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.
Successful aging/Delayed hearing intervention (SA/DHI) group
ACTIVE 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.
Interventions
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- University of North Carolinacollaborator
- University of South Floridacollaborator
- University of Minnesotacollaborator
- University of Mississippi Medical Centercollaborator
- Wake Forest Universitycollaborator
- Mayo Cliniccollaborator
- National Institute on Aging (NIA)collaborator
- NYU Langone Healthcollaborator
Study Sites (4)
Johns Hopkins Comstock Center for Public Health Research and Prevention
Hagerstown, Maryland, 21740, United States
University of Minnesota
Minneapolis, Minnesota, 55415, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Wake Forest University
Winston-Salem, North Carolina, 27104, United States
Related Publications (1)
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.
PMID: 26414855BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank R Lin, MD, PhD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Josef Coresh, MD, PhD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2022
First Posted
September 8, 2022
Study Start
January 12, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- We will share data 1 year following publication of the main results paper for the trial, unless NIH policy dictates that data be shared sooner.
- Access Criteria
- To be determined
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.