Aging, Cognition, and Hearing Evaluation in Elders Study

Study Overview
=================
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.

Official Title
-----------------
Aging, Cognition, and Hearing Evaluation in Elders Pilot Study

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Other: Best practices hearing rehabilitative treatment
* Other: Successful aging intervention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hearing intervention<br>Best practices hearing rehabilitative treatment | Other: Best practices hearing rehabilitative treatment<br>* Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.<br>|
| Placebo Comparator: Successful aging intervention<br>Successful aging intervention | Other: Successful aging intervention<br>* One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing Handicap Inventory for the Elderly (HHIE) |  | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests |  | 6 months |