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Trial record 1 of 1 for:    improving access and affordability | hearing loss | Alabama, United States
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Improving Access and Affordability of Adult Hearing Healthcare

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ClinicalTrials.gov Identifier: NCT04671381
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of Alabama, Tuscaloosa

Brief 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 personal sound amplification products (PSAPs), it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.

Condition or disease Intervention/treatment Phase
Hearing Loss Behavioral: Hearing Evaluation Device: Personal Sound Amplification Product (PSAP) Fitting and Orientation Behavioral: Four Weeks of Aural Rehabilitation Device: Provision of Personal Sound Amplification Products (PSAPs) Not Applicable

Detailed Description:

The design for this study is outlined below according to each Aim.

Aim 1: To identify the effectiveness of personal sound amplification products (PSAPs) 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 PSAP benefit, promote PSAP use and lead to increased quality of life (QOL).

Aim 1 will assess the effectiveness of over-the-counter (OTC) PSAPs for our participant population and Aim 2 will implement an AR program. With Aim 1, hearing loss will be assessed and a PSAP 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 PSAP 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 PSAP orientations and a third audiologist (A3) will perform the follow-up speech perception testing in weeks 8 - 9. Speech testing will occur before a second real ear session and PSAP adjustments are made to individual devices. Finally, the 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prior to the hearing evaluation, participants will be randomly placed in one of three groups. 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 PSAP without assistance from an audiologist for providing programming, maintenance or care information (OTC-only). The AR programming will be provided by trained Community Health Advisors (CHAs). Both the ABP and OTC-only groups initially will attend general health information sessions in-place of the AR program. Once the ABP+AR groups have completed their AR sessions, the ABP and the OTC-only groups will attend the AR programming sessions. By using this service-delivery model, it will be possible to analyze the effectiveness of the AR programming, separate from any benefits that might occur simply by meeting with others in a group setting.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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. 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 PSAP orientations and a third audiologist (A3) will perform the follow-up speech perception testing.
Primary Purpose: Treatment
Official Title: Improving Access and Affordability of Adult Hearing Healthcare: Effectiveness of Community-based Interventions in West Central and South Alabama
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Hearing Evaluation
Behavioral thresholds for pure tones will be conducted along with speech perception measures.

Device: Personal Sound Amplification Product (PSAP) Fitting and Orientation
Study participants will be fitted with binaural PSAPs in addition to receiving information on how to use and care for their devices.
Other Name: Over-the-Counter Hearing Aid Fitting and Orientation

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.

Active Comparator: 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.
Behavioral: Hearing Evaluation
Behavioral thresholds for pure tones will be conducted along with speech perception measures.

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.

Active Comparator: 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.
Behavioral: Hearing Evaluation
Behavioral thresholds for pure tones will be conducted along with speech perception measures.

Device: Provision of Personal Sound Amplification Products (PSAPs)
Study participants will receive binaural PSAPs. Participants will fit their PSAPs based on manufacturer guidelines without the help of an audiologist.
Other Name: Provision of Over-the Counter Hearing Aids




Primary Outcome Measures :
  1. Measuring Change in the Hearing Handicap Inventory for Elderly (HHIE) Outcomes [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]
    Twenty-five questions of the Hearing Handicap Inventory for Elderly (HHIE) measure emotional and social/situational consequences of hearing loss, including feelings of embarrassment, social isolation, and frustration. Scores range from 0 to 100 with higher scores indicative of poorer performance.

  2. Measuring Change in International Outcome Inventory for Hearing Aids (IOI-HA) Outcomes [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]
    The International Outcome Inventory for Hearing Aids (IOI-HA) is an eight-item inventory that assesses daily use of over-the-counter hearing aid use, over-the-counter hearing aid benefit, and activity limitations to name a few. This is a scaled qualitative measure that assesses outcomes over time.


Secondary Outcome Measures :
  1. Measuring Change in Northwestern University-6 (NU-6) Word Recognition Outcomes [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 8 to 9 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]
    This test will assess word recognition in quiet. Binaural testing will be performed at 65 dBA in the sound field. A percentage correct word understanding will be obtained. A higher scores is indicative of better performance.

  2. Measuring Change in Quick Speech In Noise (SIN) Word Recognition Outcomes [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 8 to 9 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]
    The participant will be instructed to repeat the presented sentences in noise via a speaker presented at 0˚ azimuth. The correctly identified target words will be totaled and then subtracted from 25.5 to obtain the Signal-to-Noise Ratio (SNR) loss. A higher score is indicative of poorer performance.

  3. Measuring Change in the Client Oriented Scale of Improvement (COSI) [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]
    The Client Oriented Scale of Improvement (COSI) is a 16-item clinician-administered survey that addresses how the participants' five most important listening difficulties have been alleviated with over-the-counter hearing aid use. This is a qualitative scale that measures improvement over time.

  4. Measuring Change in the Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]
    The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item survey that computes PSAP-benefit by calculating the difference between aided and unaided conditions. It is a qualitative scale that measures the extent of change over time.

  5. Measuring Change in the World Health Organization Quality of Life-Age (WHOQOL-AGE) Survey [ Time Frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year. ]
    The World Health Organization Quality of Life-Age (WHOQOL-AGE) survey is a 13-item scale that examines quality of life in adults as they age. It is a qualitative rating scale that can help to identify change in performance over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671381


Contacts
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Contact: Marcia J Hay-McCutcheon, PhD 205-348-4572 mhaymccu@ua.edu

Locations
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United States, Alabama
The University of Alabama Recruiting
Tuscaloosa, Alabama, United States, 35487
Contact: Marcia J Hay-McCutchoen, PhD    205-348-4572    mhaymccu@ua.edu   
Sponsors and Collaborators
University of Alabama, Tuscaloosa
University of Alabama at Birmingham
Investigators
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Principal Investigator: Marcia J Hay-McCutcheon, PhD The University of Alabama, Tuscaloosa
Publications of Results:
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Responsible Party: University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT04671381    
Other Study ID Numbers: 19-03-2170
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data that has been collected during this clinical trial and after it has been de-identified will be shared.
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning 3 months following article publication and ending 5 years after the article has been published.
Access Criteria: Researchers who provide a methodologically sound proposal will be given access to the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases