ACHIEVE Brain Health Follow-Up Study

NCT05532657 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2025-11-10

No results posted yet for this 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.

Conditions

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • University of North Carolina

    collaborator OTHER
  • University of South Florida

    collaborator OTHER
  • University of Minnesota

    collaborator OTHER
  • University of Mississippi Medical Center

    collaborator OTHER
  • Wake Forest University

    collaborator OTHER
  • Mayo Clinic

    collaborator OTHER
  • National Institute on Aging (NIA)

    collaborator NIH
  • NYU Langone Health

    collaborator OTHER
  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Frank R Lin, MD, PhD · Johns Hopkins University

  • Josef Coresh, MD, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
73 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532657 on ClinicalTrials.gov