ACHIEVE RCT - Aging and Cognitive Health Evaluation in Elders Randomized Control Trial
The ACHIEVE study will be a randomized controlled trial nested within the Atherosclerosis
Risk in Communities (ARIC) study. 850 70-84 year-old cognitively normal older adults
with hearing loss will be randomized 1:1 to the hearing intervention (hearing needs
assessment, fitting of hearing devices, education/counseling) or successful aging
intervention (individual sessions with a health educator covering healthy aging topics).
Post baseline, participants will be followed semi-annually for 3 years.
NIH/NIA 1 R01 AG055426-01
USF Principal Investigator: Theresa Chisolm PhD
ClinicalTrials.gov: NCT03243422
ACHIEVE HIFU – Hearing Intervention Follow-Up Study, Randomized Trial of Telehealth
vs. Conventional Hearing Care Delivery in the ACHIEVE Study with current hearing aid
users
Multi-site randomized trial comparing conventional in-person hearing health care (HHC)
versus in-person HHC plus telehealth audiology sessions among existing hearing aid
users. Participants will be recruited from the ongoing Aging & Cognitive Health Evaluation
in Elders (ACHIEVE) randomized trial in which the investigators recruited 977 adults
ages 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October
2019 who were randomized to a hearing intervention (i.e., conventional clinic-based
delivery of hearing services and technologies) versus a successful aging education
control intervention (i.e., one-on-one sessions with a health educator on topics important
for healthy aging). From 2021-2022, as participants in the hearing intervention group
(fixed sample, n=490) complete the pre-specified three years of follow-up in the ACHIEVE
trial, the investigators will recruit these existing hearing aid users and randomize
the participants 1:1 to receive continued conventional clinic-based delivery of hearing
care services versus a model that incorporates telehealth. Accounting for loss to
follow-up and death, the investigators conservatively estimate that n=400 participants
currently in the hearing intervention group will be recruited into this two-year follow-up
study.
NIH/NIDCD 1 R01 DC019408-01
USF Principal investigator: Victoria Sanchez AuD PhD
Clinicaltrials.gov: NCT05070429
ACHIEVE SAFU – Successful Aging Group Follow-Up Study, Randomized Trial of Telehealth
vs. Conventional Hearing Care Delivery in the ACHIEVE Study with new hearing aid users
Multi-site randomized trial comparing conventional in-person hearing health care (HHC)
versus in-person HHC plus telehealth audiology sessions among new hearing aid users.
Participants will be recruited from the ongoing Aging & Cognitive Health Evaluation
in Elders (ACHIEVE) randomized trial in which the investigators recruited 977 adults
ages 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October
2019 who were randomized to a hearing intervention (i.e., conventional clinic-based
delivery of hearing services and technologies) versus a successful aging education
control intervention (i.e., one-on-one sessions with a health educator on topics important
for healthy aging). From 2021-2022, as participants in the successful aging group
(fixed sample, n=487) complete the pre-specified three years of follow-up in the ACHIEVE
trial, the investigators will recruit these new hearing aid users and randomize the
participants 1:1 to receive continued conventional clinic-based delivery of hearing
care services versus a model that incorporates telehealth. Accounting for loss to
follow-up and death, the investigators conservatively estimate that n=390 participants
currently in the hearing intervention group will be recruited into this two-year follow-up
study.
NIH/NIDCD 1 R01 DC019408-01
USF Principal investigator: Victoria Sanchez AuD PhD
Clinicaltrials.gov: NCT05070429
ACHIEVE BHFU – Brain Health Follow-Up Study, Long-Term Effects of Hearing Intervention
on Brain Health in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized
study– (ACHIEVE Brain Health)
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.
NIH/NCDID 1R01AG076518-01
USF Principal Investigator: Victoria Sanchez AuD PhD
Clinicaltrials.gov: NCT05532657
ACHIEVE EARLHI – Early-Stage Age Related Hearing Loss Investigation: A Pilot Study
to asses mechanisms linking early Age-Related Hearing Loss and Alzheimer’s Disease
and Related Dementias
The target risk group is 55-75-year old people with early-stage age-related hearing
loss (ARHL) and amnestic mild cognitive impairment. The RCT, entitled “Early Age-Related
Hearing Loss Investigation (EARHLI). The mechanisms linking ARHL and Alzheimer’s
Disease and Related Dementias (AD/ADRD) are unknown, but reduced social engagement
and changes in brain organization/connectivity have been proposed. EARHLI focuses
on early ARHL in middle and early older age, a critical time for AD/ADRD prevention.
Unlike ACHIEVE, EARHLI also measures brain organization/connectivity. EARHLI will
be a phase II 1:1 RCT of a hearing aid-based intervention versus a comparator (health
education program) conducted over 12 months in 150 participants (n=76 undergoing MRI)
with early ARHL at risk for AD/ADRD. The overarching hypothesis is that the hearing
intervention will lead to improved social engagement and brain organization/connectivity
that will lead to improved cognition compared with the comparator arm. This hypothesis
will be tested with an intent- to-treat approach comparing the hearing intervention
and comparator arms. Aim 1 is to compare change in cognitive performance measured
with the Alzheimer’s Disease Cooperative Study Preclinical Alzheimer Cognitive Composite
(ADCS-PACC; 1º outcome) and by domain-specific cognitive testing on ADCS-PACC components
(0, 6, 12 months). Aim 2 is to compare change in social engagement measured by activity
participation (1º outcome) and network size/support (at 0, 6, 12 months). Aim 3 is
to compare changes in brain organization/connectivity using task (visual task, auditory
regions of interest,1º outcome) and resting-state fMRI, and diffusion-weighted structural
connectivity (at 0, 12 months). We will explore whether social engagement and brain
organization/connectivity mediate the effects of the intervention on cognitive outcomes.
NIH/NCDID 1R01AG075083-01A1
USF Principal Investigator: Victoria Sanchez, AuD PhD
Clinicaltrials.gov: NCT05532657
Development and Assessment of Spanish-Language Toolkit for Hearing Loss Self-Management
The purpose of the study is to develop and test Spanish-language patient education
materials for hearing loss. First, we want to find out what people who speak Spanish
think should go into these materials from focus groups. Next, we want to find out
if people who speak Spanish have a better understanding of hearing loss and options
for hearing loss help after receiving these.
NIH/NIDCD R21DC018655
USF Principal Investigator: Michelle Arnold AuD PhD