Aging and Cognitive Health Evaluation in Elders (ACHIEVE)

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.

Outcomes will include assessments of cognition, social functioning, physical functioning, and
quality of life.

Inclusion Criteria:

- Age 70-84 years. Individuals aged 70-84 at the time of randomization are eligible for
participation. This age range will allow recruitment of participants who are at risk
for cognitive decline but who may also be expected to survive for the duration of the
trial. This age range is estimated to allow for potential participation of 61% of
participants currently enrolled in the ARIC study.

- Community-dwelling.

- Fluent English-speaker.

- Residency. Participants must plan to reside in the local area for the study duration.

- Audiometric hearing impairment. Participants must have adult-onset hearing impairment
with a four-frequency pure tone average (0.5, 1, 2, 4 kHz) in the better-hearing ear
of ≥ 30 decibels (dB) and <70 dB. This level of hearing impairment is the level at
which individuals would be most likely to benefit from the use of conventional
amplification devices such as hearing aids.

- Word Recognition in Quiet score ≥60% in the better ear. A word recognition in quiet
score <60% suggests hearing impairment that is too severe to benefit from conventional
amplification devices such as hearing aids.

- Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or
less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or
more; Participants must be at risk for cognitive decline in the range quantified well
by neurocognitive testing, and so must be free from more substantial cognitive
impairment at baseline.

- Willingness to participate be randomized and adhere to the protocol. Participants must
be willing and able to consent to participate in the study, be willing to be
randomized to either the Hearing intervention or to the Successful Aging intervention,
and be willing to commit to adhere to the study protocol for the duration of the trial
(3 years of a randomly assigned intervention).

Exclusion Criteria:

- Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL)

- Any self-reported hearing aid use in the past year. Trial participants will be
randomized to hearing intervention or successful aging intervention and, therefore,
participants cannot be currently already receiving treatment for their hearing loss.

- ARIC participants only: Diagnosis of adjudicated dementia based on a previous ARIC
visit or participant required a proxy to assist with completing informed consent and
responding to questions at ARIC Visit 6 or 7.

- Vision impairment (worse than 20/63 on Minnesota (MN) Near Vision Card). Participants
who cannot see (with correction) well enough to complete the neurocognitive assessment
are excluded.

- Medical contraindication to use of hearing aids (e.g., draining ear). Because hearing
aids will be the primary device used in the hearing intervention, participants with
medical contraindications to hearing aid use are excluded.

- Conductive hearing impairment as determined by a difference in air audiometry and bone
audiometry ("air-bone gap") greater than 15 dB in 2 or more contiguous frequencies in
both ears. Because the impact of a conductive (versus a sensorineural) hearing loss on
cognitive functioning may potentially differ and programming for hearing aids differs
for conductive hearing loss, participants with permanent conductive hearing loss are
excluded from the trial. Participants with an air-bone gap due to fluid in the ears or
other resolvable medical issue may be enrolled in the trial following successful
medical resolution of the cause of the air-bone gap.

- Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis