Improving Access and Affordability of Adult Hearing Healthcare
NCT ID: NCT04671381
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2021-01-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Audiology Best Practices plus Aural Rehabilitation (ABP+AR)
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.
Hearing Evaluation
Behavioral thresholds for pure tones will be conducted along with speech perception measures.
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.
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.
Audiology Best Practices (ABP)
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.
Hearing Evaluation
Behavioral thresholds for pure tones will be conducted along with speech perception measures.
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.
Over-the-Counter Only (OTC-Only)
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.
Hearing Evaluation
Behavioral thresholds for pure tones will be conducted along with speech perception measures.
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.
Interventions
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Hearing Evaluation
Behavioral thresholds for pure tones will be conducted along with speech perception measures.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Live in West Central or South Alabama
* 40 years of age or older
Exclusion Criteria
40 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
University of Alabama, Tuscaloosa
OTHER
Responsible Party
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Principal Investigators
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Marcia J Hay-McCutcheon, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Alabama, Tuscaloosa
Locations
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The University of Alabama
Tuscaloosa, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Tillman TW, Carhart R. An expanded test for speech discrimination utilizing CNC monosyllabic words. Northwestern University Auditory Test No. 6. SAM-TR-66-55. Tech Rep SAM-TR. 1966 Jun:1-12. doi: 10.21236/ad0639638. No abstract available.
Schow RL, Nerbonne MA. Communication screening profile: use with elderly clients. Ear Hear. 1982 May-Jun;3(3):135-47. doi: 10.1097/00003446-198205000-00007. No abstract available.
Cox RM, Alexander GC. The International Outcome Inventory for Hearing Aids (IOI-HA): psychometric properties of the English version. Int J Audiol. 2002 Jan;41(1):30-5. doi: 10.3109/14992020209101309.
Dillon H, James A, Ginis J. Client Oriented Scale of Improvement (COSI) and its relationship to several other measures of benefit and satisfaction provided by hearing aids. J Am Acad Audiol. 1997 Feb;8(1):27-43.
Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
Caballero FF, Miret M, Power M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Olaya B, Haro JM, Ayuso-Mateos JL. Validation of an instrument to evaluate quality of life in the aging population: WHOQOL-AGE. Health Qual Life Outcomes. 2013 Oct 23;11:177. doi: 10.1186/1477-7525-11-177.
Etymotic. QuickSIN Speech-in-Noise Test. Elk Grove Village, IL 2006.
Hay-McCutcheon MJ, Hubbard A, Brothers EB, Straub K, Allen RS, Hardy C, Tye-Murray N. Development and Implementation of an Aural Rehabilitation Program Using Community Health Workers in Rural Alabama. Perspect ASHA Spec Interest Groups. 2024 Oct;9(5):1367-1376. doi: 10.1044/2024_PERSP-24-00083. Epub 2024 Aug 28.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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19-03-2170
Identifier Type: -
Identifier Source: org_study_id
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