Clinical trial NCT05532657: ACHIEVE Brain Health Follow-Up Study
Official title: Long-term Effects of Hearing Intervention on Brain Health in the Aging and Cognitive Health Evaluation in Elders Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Aging
Cognitive Decline
Mild Cognitive Impairment
Dementia
Hearing Loss
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: University of South Florida
name: University of Minnesota
name: University of Mississippi Medical Center
name: Wake Forest University
name: Mayo Clinic
name: National Institute on Aging (NIA)
name: NYU Langone Health
First posted: 2022-09-08
Enrollment: 629
Sex: ALL
Minimum age (years): 73
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in global cognition
timeFrame: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)
measure: Mild cognitive impairment (MCI) / dementia
timeFrame: 6 years
Secondary outcomes:
measure: Change in cognition memory domain
timeFrame: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)
measure: Change in cognition executive function domain
timeFrame: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)
measure: Change in cognition language domain
timeFrame: ACHIEVE Baseline, ACHIEVE-BHFU Year 3 (~6 years)
measure: Change in regional brain volumes
timeFrame: 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)
measure: Change in white matter tract integrity
timeFrame: 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)
Other outcomes:
Locations:
city: Hagerstown
country: United States
facility: Johns Hopkins Comstock Center for Public Health Research and Prevention
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Johns Hopkins University
name: Frank R Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Josef Coresh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.