Aging Clinical Trial
— ACHIEVE-BHFUOfficial title:
Long-term Effects of Hearing Intervention on Brain Health in the Aging and Cognitive Health Evaluation in Elders Randomized Study
Verified date | April 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 859 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 73 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Comstock Center for Public Health Research and Prevention | Hagerstown | Maryland |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Mayo Clinic, National Institute on Aging (NIA), NYU Langone Health, University of Minnesota, University of Mississippi Medical Center, University of North Carolina, University of South Florida, Wake Forest University |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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. | ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years) | |
Secondary | 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. | ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years) | |
Secondary | 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. | ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years) | |
Secondary | 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. | 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) | |
Secondary | 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. | 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) |
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