Aging, Cognition, and Hearing Evaluation in Elders Study

Hearing Loss Clinical Trial

— ACHIEVE-P  

Official title:

Aging, Cognition, and Hearing Evaluation in Elders Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412254
• Other study ID #: IRB00067383
• Secondary ID: R34AG046548
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 8, 2021

Study information

• Verified date: March 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Other:
• Best practices hearing rehabilitative treatment
Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.
• Successful aging intervention
One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant

Locations

Country	Name	City	State
United States	Johns Hopkins Comstock Center for Public Health Research	Hagerstown	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing Handicap Inventory for the Elderly (HHIE)		6 month follow-up
Secondary	Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests		6 months