NCT04671381

Improving Access and Affordability of Adult Hearing Healthcare

Improving Access and Affordability of Adult Hearing Healthcare: Effectiveness of Community-based Interventions in West Central and South Alabama

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: University of Alabama, Tuscaloosa · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This project will address quality of care issues associated with hearing loss in adults who have mild-to-moderate hearing loss and who have no access to hearing healthcare. Through the use of three different interventions involving over-the-counter hearing aids, it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.

Detailed description

The design for this study is outlined below according to each Aim. Aim 1: To identify the effectiveness of over-the-counter hearing aids (OTC HAs) for decreasing hearing handicap and improving speech perception in adults with no access to hearing health care. Aim 2: To implement an adult aural rehabilitation (AR) program for those without access to hearing health care to improve OTC HA benefit, promote OTC HA use and lead to increased quality of life (QOL). Aim 1 will assess the effectiveness of OTC HAs for our participant population and Aim 2 will implement an AR program. With Aim 1, hearing loss will be assessed and an OTC HA will be provided. Prior to the hearing evaluation, participants will be randomly placed in one of three groups to assess the effectiveness of the AR program (Aim 2). The three groups include those who will receive the current best practices care from an audiologist (ABP), those who will receive the ABP plus an aural rehabilitation program (ABP+AR), and finally, those who will receive only an OTC HA without assistance from an audiologist for providing programming, maintenance or care information (OTC-only). Both the ABP and OTC-only groups initially will attend general health information sessions in-place of the AR program. Local health care providers who have training in general health areas such as nutrition, diabetes, obesity, and heart health to name a few, will provide the General Health and Wellness programming. Once the ABP+AR groups have completed their AR sessions, the ABP and the OTC-only groups will attend the AR programming sessions. This testing layout and schedule is provided in the table below. Randomization will occur for each county visited and for the participants. Specifically, five counties will each receive a code and these codes will be randomized to determine when the study will take place in that area. All five regions will be included over a one-year period. Participant randomization will occur by generating three groups of random participant numbers and then assigning each participant to their designated group. Only the PI and the project manager will have access to the randomization lists. The PI will generate the randomization lists and the Project Manager will assign the participants accordingly to each group. The randomization lists will be kept on a password-protected computer and only accessible by the PI or Project Manager. Audiologists will be blinded to the intervention condition for participants. Specifically, two audiologists (A1 and A2) will conduct the initial hearing evaluations. A2 will perform the OTC HA settings and orientations and a third audiologist (A3) will perform the follow-up speech perception testing in weeks 8 - 9. A second post-speech perception testing for all participants in week 14 will be conducted by A1. The entire program will take place over a 14-week period for one county at a time. County 1 will begin at Week 1 and the remaining four regions will be stratified such that testing will begin at Week 9, 10 or 11 consecutively for each region. The stratification will be done to ensure that testing takes place in each area over a one-year period, and also, to avoid simultaneous testing at two sites. Finally, all participants who complete the study in years 1 and 2 will be invited back to complete speech perception testing and the AR surveys one year after they complete the study.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
BEHAVIORAL	Hearing Evaluation	Behavioral thresholds for pure tones will be conducted along with speech perception measures.
DEVICE	Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation	Study participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices.
BEHAVIORAL	Four Weeks of Aural Rehabilitation	Participants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss.
DEVICE	Provision of Over-the-Counter Hearing Aids	Study participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist.

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-12-17
• Last updated: 2024-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study