earing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in ~40% of those over the age of 60 years. Only 20% of these individuals purchase and use hearing aids. The Over-the-Counter Hearing Aid Act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. While this legislation directs the Food and Drug Administration (FDA) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. Patients do not have the evidence they need to decide between modes of acquiring hearing aids. The current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. Goals and Aims: The overall goal of this proposal is to compare two over-the-counter (OTC) models of hearing aid provision against audiology-based best practice (AB), with and without supplemental video learning modules. This goal will be achieved through the following two specific aims: Aim 1. To determine whether brief consumer decides (bCD) and Efficient Fit (EF) models for hearing aid provision are non-inferior to current audiology-based best practices (AB). Aim 2. To evaluate the effectiveness of a video-based supplemental education program in empowering and activating the new hearing aid wearer. Study Design: A multi-site prospective randomized clinical trial with six parallel arms will be conducted. Participants will be randomized to one of the six arms representing 3 x 2 factorial combinations of service-delivery model (AB, bCD, EF) and video-learning module use (+/-). The targeted enrollment for each branch is 51 (justified below), for a total N of 306 with complete data. The study PIs and leads at each clinical site will be blinded to group assignment. The site leads will conduct the baseline and outcome measures. Comparators: This study has two key comparisons regarding hearing aid provision to older adults with hearing difficulties. First, two patient-fit models of hearing aid provision (bCD, EF) are compared to the current audiologist-fit best-practices approach (AB). Second, the provision of hearing aids with hearing-aid-related video learning modules (C2Hear+) is compared to use of non-hearing-aid-related video learning modules (active control; C2Hear-). Study Population: Individuals between the ages of 50 and 79 years who have not used hearing aids previously will be recruited through advertisements placed in local media and strategically placed announcements at community centers, places of worship, and social media. Recruitment will target areas around the three research sites, which are located in racially and socioeconomically diverse areas around Chicago, IL. All participants will use English as their first language and have a score of 26 or higher on the Mini-Mental Status Exam. Participants will respond to an advertisement seeking individuals with mild to moderate hearing difficulties. A total of 350 individuals will be recruited with the ultimate goal of complete data collection on 51 individuals per study arm (total n = 306). Outcomes: Hearing aid benefit will be compared for participants randomly assigned to AB, bCD, and EF arms using the Profile for Hearing Aid Performance (PHAP), Hearing Handicap Inventory for the Elderly (HHIE), and other questionnaires. The primary outcome measure in the service delivery comparison will be the global benefi
|Effective start/end date||6/1/20 → 6/30/25|
- Patient-Centered Outcomes Research Institute (HL-2019C1-16094)
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