Improving Access and Affordability of Adult Hearing Healthcare

NCT04671381 | Recruiting DMC FDA Device

• 1 other identifier: 19-03-2170
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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)

  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)

  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

  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.

Study Arms (3)

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.

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.

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.

Behavioral: Hearing Evaluation; Device: Provision of Over-the-Counter Hearing Aids

Interventions

Hearing Evaluation BEHAVIORAL

Behavioral thresholds for pure tones will be conducted along with speech perception measures.

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 Orientation DEVICE

Study participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices.

Also known as: Over-the-Counter Hearing Aid Fitting and Orientation

Audiology Best Practices plus Aural Rehabilitation (ABP+AR)

Four Weeks of Aural Rehabilitation BEHAVIORAL

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); Audiology Best Practices plus Aural Rehabilitation (ABP+AR)

Provision of Over-the-Counter Hearing Aids DEVICE

Study participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist.

Also known as: Provision of Over-the Counter Hearing Aids

Over-the-Counter Only (OTC-Only)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

The University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 5296571 RESULT

• 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.

  PMID: 7095322 RESULT

• 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.

  PMID: 12467367 RESULT

• 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.

  PMID: 9046067 RESULT

• 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.

  PMID: 7789669 RESULT

• 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.

  PMID: 24152691 RESULT

• Etymotic. QuickSIN Speech-in-Noise Test. Elk Grove Village, IL 2006.

  RESULT

• 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.

  PMID: 40123580 DERIVED

MeSH Terms

Conditions

Hearing Loss

Interventions

Correction of Hearing Impairment

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marcia J Hay-McCutcheon, PhD

  The University of Alabama, Tuscaloosa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia J Hay-McCutcheon, PhD

CONTACT

205-348-4572; mhaymccu@ua.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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 OTC HA settings and orientations and a third audiologist (A3) will perform the follow-up speech perception testing.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)