Aging, Cognition, and Hearing Evaluation in Elders Study
ACHIEVE-P
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2021
CompletedApril 8, 2021
March 1, 2021
5.9 years
April 1, 2015
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Hearing Handicap Inventory for the Elderly (HHIE)
6 month follow-up
Secondary Outcomes (1)
Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests
6 months
Study Arms (2)
Hearing intervention
ACTIVE COMPARATORBest practices hearing rehabilitative treatment
Successful aging intervention
PLACEBO COMPARATORSuccessful aging intervention
Interventions
Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.
One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Johns Hopkins Comstock Center for Public Health Research
Hagerstown, Maryland, 21740, United States
Related Publications (1)
Deal JA, Albert MS, Arnold M, Bangdiwala SI, Chisolm T, Davis S, Eddins A, Glynn NW, Goman AM, Minotti M, Mosley T, Rebok GW, Reed N, Rodgers E, Sanchez V, Sharrett AR, Coresh J, Lin FR. A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study. Alzheimers Dement (N Y). 2017 Jun 21;3(3):410-415. doi: 10.1016/j.trci.2017.06.003. eCollection 2017 Sep.
PMID: 29067347DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Lin
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2015
First Posted
April 9, 2015
Study Start
May 1, 2015
Primary Completion
March 8, 2021
Study Completion
March 8, 2021
Last Updated
April 8, 2021
Record last verified: 2021-03