Improving Access and Affordability of Adult Hearing Healthcare

University of Alabama, Tuscaloosa

Status: Enrolling

Conditions: Hearing Loss

Treatments: Device: Provision of Over-the-Counter Hearing Aids; Behavioral: Four Weeks of Aural Rehabilitation; Behavioral: Hearing Evaluation; Device: Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation

Study type: Interventional

Funder types: Other

Identifiers

NCT04671381

19-03-2170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mild-to-moderate hearing loss
• Live in West Central or South Alabama
• 40 years of age or older

Exclusion criteria

• Medical conditions resulting in severe cognitive impairment (e.g., stroke, head injury, senile dementia or Alzheimer's disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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210 participants in 3 patient groups

Audiology Best Practices plus Aural Rehabilitation (ABP+AR)

Experimental group

Description:

This experimental group will receive a hearing evaluation, an over-the-counter hearing aid fitting and orientation, and four-weeks of an aural rehabilitation program conducted by specially-trained community health workers. Additionally, these adults will complete pre- and post-questionnaires and speech perception testing.

Treatment:

Device: Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation

Behavioral: Hearing Evaluation

Behavioral: Four Weeks of Aural Rehabilitation

Audiology Best Practices (ABP)

Active Comparator group

Description:

This comparison group of adults with hearing loss will receive a hearing evaluation and over-the-counter hearing aid fitting and orientation. The aural rehabilitation program will not be provided initially. These participants will complete pre- and post-questionnaires and speech perception testing.

Treatment:

Behavioral: Hearing Evaluation

Behavioral: Four Weeks of Aural Rehabilitation

Over-the-Counter Only (OTC-Only)

Active Comparator group

Description:

This comparison group of adults with hearing loss will receive a hearing evaluation. They will be provided with over-the-counter hearing aids but the audiologist will not assist with fitting the aids or providing an orientation. This arm mimics what would happen when a consumer privately purchases over-the-counter hearing aids. They will complete pre- and post-questionnaires and speech perception testing.

Treatment:

Behavioral: Hearing Evaluation

Device: Provision of Over-the-Counter Hearing Aids