Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Locations
- 1
- Primary Endpoint
- Measure of Cognitive function using Mini-Cog
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
No Hearing Assistance Device (HAD) First
Sham hearing aid device
Intervention: cognitive testing with HAD (PockeTalker) First (Diagnostic Test)
No Hearing Assistance Device (HAD) First
Sham hearing aid device
Intervention: Cognitive testing without HAD First (Diagnostic Test)
Hearing Assistance Device (HAD) First
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.
Intervention: cognitive testing with HAD (PockeTalker) First (Diagnostic Test)
Hearing Assistance Device (HAD) First
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.
Intervention: Cognitive testing without HAD First (Diagnostic Test)
Outcomes
Primary Outcomes
Measure of Cognitive function using Mini-Cog
Time Frame: 20 Minutes
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.
Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE)
Time Frame: 20 Minutes
HHIE-S is a valid, robust test for identifying hearing-impaired elderly, irrespective of the audiometric definition used to finally diagnose hearing difficulties.
Secondary Outcomes
No secondary outcomes reported