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Aging, Cognition, and Hearing Evaluation in Elders Study (ACHIEVE-P)

Johns Hopkins University logo

Johns Hopkins University

Status

Completed

Conditions

Hearing Loss

Treatments

Other: Successful aging intervention
Other: Best practices hearing rehabilitative treatment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02412254
IRB00067383
R34AG046548 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old adults with hearing loss to best-practices hearing rehabilitative treatment (hearing assessment, counseling, fitting of amplification devices) versus a successful aging intervention (one-on-one counseling/education sessions on successful aging topics). Participants will be followed for 6 months, and outcomes will focus on communication, quality of life, cognition, and other functional surveys. This pilot study is in preparation for a larger planned trial to investigate if hearing loss treatment can reduce cognitive decline and dementia in older adults.

Enrollment

40 patients

Sex

All

Ages

70 to 84 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Age 70-84 years.
  • Community-dwelling.
  • Fluent English-speaker.
  • Residency. Participants must plan to reside in the local area for the study duration (6 months).
  • Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a pure tone average (0.5, 1, and 2 kHz) in the better-hearing ear of ≥ 30 decibels and <70 dB.
  • Word Recognition in Quiet score >60% bilaterally.
  • 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
  • Willingness to participate. 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 follow the study protocol for the duration of the trial.

Exclusion Criteria

Potential candidates for enrollment who meet one or more of t he following criteria are excluded from participation in the study:

  • Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL)
  • Self-reported hearing aid use in the past year (>5 hours/week).
  • Vision impairment (worse than 20/40 on MN Near Vision Card).
  • Medical contraindication to use of hearing aids (e.g., draining ear).
  • 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.
  • Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis
  • No participants are excluded based on race or sex

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups, including a placebo group

Hearing intervention
Active Comparator group
Description:
Best practices hearing rehabilitative treatment
Treatment:
Other: Best practices hearing rehabilitative treatment
Successful aging intervention
Placebo Comparator group
Description:
Successful aging intervention
Treatment:
Other: Successful aging intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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