Hearing LossNCT04671381
Improving Access and Affordability of Adult Hearing Healthcare
A study testing Hearing Evaluation, Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation and Four Weeks of Aural Rehabilitation in people with Hearing Loss, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing Evaluation, Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation and Four Weeks of Aural Rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild-to-moderate hearing loss
- Live in West Central or South Alabama
- 40 years of age or older
Who cannot join
- Medical conditions resulting in severe cognitive impairment (e.g., stroke, head injury, senile dementia or Alzheimer's disease)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama
Tuscaloosa, Alabama, 35487
Marcia J Hay-McCutchoen, PhD, 205-348-4572, mhaymccu@ua.edu
About this study
Official title: Improving Access and Affordability of Adult Hearing Healthcare: Effectiveness of Community-based Interventions in West Central and South Alabama
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.
Read the 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
- Being tested
- Hearing Evaluation, Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation, Four Weeks of Aural Rehabilitation, Provision of Over-the-Counter Hearing Aids
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing EvaluationBehavioural
Behavioral thresholds for pure tones will be conducted along with speech perception measures.
Over-the-Counter Hearing Aid (OTC HA) Fitting and OrientationDevice
Also called Over-the-Counter Hearing Aid 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 RehabilitationBehavioural
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 AidsDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Audiology Best Practices plus Aural Rehabilitation (ABP+AR) | Experimental | 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. Receives: Behavioral: Hearing Evaluation; Device: Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation; Behavioral: Four Weeks of Aural Rehabilitation |
| Audiology Best Practices (ABP) | Active comparator | 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. Receives: Behavioral: Hearing Evaluation; Behavioral: Four Weeks of Aural Rehabilitation |
| Over-the-Counter Only (OTC-Only) | Active comparator | 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. Receives: Behavioral: Hearing Evaluation; Device: Provision of Over-the-Counter Hearing Aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Change in the Hearing Handicap Inventory for Elderly (HHIE) Outcomes
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.
Measured: 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.
Measuring Change in International Outcome Inventory for Hearing Aids (IOI-HA) Outcomes
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.
Measured: 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.
Secondary outcomes (5)
Measuring Change in Northwestern University-6 (NU-6) Word Recognition Outcomes
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.
Measured: 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.
Measuring Change in Quick Speech In Noise (SIN) Word Recognition Outcomes
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.
Measured: 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.
Measuring Change in the Client Oriented Scale of Improvement (COSI)
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.
Measured: 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.
Measuring Change in the Abbreviated Profile of Hearing Aid Benefit (APHAB)
The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item survey that computes OTC HA-benefit by calculating the difference between aided and unaided conditions. It is a qualitative scale that measures the extent of change over time.
Measured: 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.
Measuring Change in the World Health Organization Quality of Life-Age (WHOQOL-AGE) Survey
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 HA 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Marcia J Hay-McCutcheon, PhD, Principal investigator, The University of Alabama, Tuscaloosa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671381
- Sponsor's protocol ID
- 19-03-2170
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2020
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data that has been collected during this clinical trial and after it has been de-identified will be shared.
Publications
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.
PubMed 5296571Schow 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.
PubMed 7095322Cox 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.
PubMed 12467367Dillon 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.
PubMed 9046067Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
PubMed 7789669Caballero 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.
PubMed 24152691Etymotic. 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.
PubMed 40123580
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access and Affordability of Adult Hearing Healthcare: Effectiveness of Community-based Interventions in West Central and South Alabama
- ClinicalTrials.gov ID
- NCT04671381
- Acronym / sponsor ID
- 19-03-2170
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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 HA 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.
| Arm | Type | Receives |
|---|---|---|
| Audiology Best Practices plus Aural Rehabilitation (ABP+AR) | Experimental | Behavioral: Hearing Evaluation, Device: Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation, Behavioral: Four Weeks of Aural RehabilitationThis 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. |
| Audiology Best Practices (ABP) | Active comparator | Behavioral: Hearing Evaluation, Behavioral: Four Weeks of Aural RehabilitationThis 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. |
| Over-the-Counter Only (OTC-Only) | Active comparator | Behavioral: Hearing Evaluation, Device: Provision of Over-the-Counter Hearing AidsThis 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild-to-moderate hearing loss
- Live in West Central or South Alabama
- 40 years of age or older
Key exclusion criteria (1 listed)
- Medical conditions resulting in severe cognitive impairment (e.g., stroke, head injury, senile dementia or Alzheimer's disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing EvaluationBehavioral thresholds for pure tones will be conducted along with speech perception measures. | Behavioural | Audiology Best Practices (ABP), Audiology Best Practices plus Aural Rehabilitation (ABP+AR), Over-the-Counter Only (OTC-Only) |
| Over-the-Counter Hearing Aid (OTC HA) Fitting and OrientationAlso: Over-the-Counter Hearing Aid Fitting and OrientationStudy participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices. | Device | Audiology Best Practices plus Aural Rehabilitation (ABP+AR) |
| Four Weeks of Aural RehabilitationParticipants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss. | Behavioural | Audiology Best Practices (ABP), Audiology Best Practices plus Aural Rehabilitation (ABP+AR) |
| Provision of Over-the-Counter Hearing AidsAlso: Provision of Over-the Counter Hearing AidsStudy participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist. | Device | Over-the-Counter Only (OTC-Only) |
Primary outcome
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.
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Results publication: PubMed 5296571Tillman 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.
- Results publication: PubMed 7095322Schow 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.
- Results publication: PubMed 12467367Cox 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.
- Results publication: PubMed 9046067Dillon 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.
- Results publication: PubMed 7789669Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
- Results publication: PubMed 24152691Caballero 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.
- Results publicationEtymotic. QuickSIN Speech-in-Noise Test. Elk Grove Village, IL 2006.
- Derived from this study: PubMed 40123580Hay-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.
- Individual participant dataSharing planned: Yes. All of the individual participant data that has been collected during this clinical trial and after it has been de-identified will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia J Hay-McCutcheon, PhD principal investigator
The University of Alabama, Tuscaloosa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Evaluation, Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation and Four Weeks of Aural Rehabilitation in people with Hearing Loss, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcia J Hay-McCutcheon, PhD (205-348-4572, mhaymccu@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04671381, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.