ACHIEVE Brain Health Follow-Up Study
NCT05532657 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 629
Last updated 2025-11-10
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 - collaborator OTHER
-
University of Mississippi Medical Center
collaborator OTHER -
Wake Forest University
collaborator OTHER - collaborator OTHER
-
National Institute on Aging (NIA)
collaborator NIH - collaborator OTHER
- 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
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