Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents

Study Overview
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Brief Summary
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The purpose of the study is to see if a commercially available hearing assistance device called the PockeTalker has an effect on performance on cognitive (memory and thinking) tests among skilled nursing facility residents. Investigators are asking residents to perform cognitive tests with and without hearing assistance equipment known as PockeTalkers. This study will be conducted at one urban Skilled Nursing Facility (SNF) with the goal of understanding the extent to which hearing impairment impacts commonly used cognitive impairment measures for clinical assessment. Cognitive performance will be measured, cerumen occlusion, and perceived hearing.

Official Title
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Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents

Conditions
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Hearing Impairment

Intervention / Treatment
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* Diagnostic Test: cognitive testing with HAD (PockeTalker) First
* Diagnostic Test: Cognitive testing without HAD First


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admitted to unit of intervention ability to communicate and follow simple commands capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent. Exclusion Criteria: not on the unit of intervention obtunded or comatose state inability to communicate verbally inability to consent and without surrogate non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hearing Assistance Device (HAD) First<br>Tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second. Participants randomized to HAD first will use a Hearing Aid Device. | Diagnostic Test: cognitive testing with HAD (PockeTalker) First<br>* tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.<br>* Other names: PockeTalker Hearing Aid Device;Diagnostic Test: Cognitive testing without HAD First<br>* tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.<br>|
| Active Comparator: No Hearing Assistance Device (HAD) First<br>Sham hearing aid device | Diagnostic Test: cognitive testing with HAD (PockeTalker) First<br>* tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.<br>* Other names: PockeTalker Hearing Aid Device;Diagnostic Test: Cognitive testing without HAD First<br>* tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Cognitive function using Mini-Cog | three-item recall and a clock draw test. 24 Medical assistants have been trained and have employed this test successfully in primary care practices. The Mini-Cog has test characteristics that are comparable to any other brief instrument and exceeds most in accuracy or predictive quality. | 20 Minutes | 
| Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE) | HHIE-S is a valid, robust test for identifying hearing-impaired elderly, irrespective of the audiometric definition used to finally diagnose hearing difficulties. | 20 Minutes |