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Accessible Hearing Care Interventions for Hearing Loss

N/A

Recruiting

Led By Marcia J Hay-McCutcheon, PhD

Research Sponsored by University of Alabama, Tuscaloosa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

40 years of age or older

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well three different interventions work to improve quality of care for adults with mild-to-moderate hearing loss who don't have access to hearing healthcare.

Who is the study for?

This trial is for adults over 40 living in West Central or South Alabama who have mild-to-moderate hearing loss. It's not open to those with severe cognitive impairments from conditions like stroke, head injury, dementia, or Alzheimer's disease.

What is being tested?

The study tests three interventions: providing personal sound amplification products (PSAPs), a four-week aural rehabilitation program, and PSAP fitting/orientation alongside regular hearing evaluations to improve hearing healthcare access and affordability.

What are the potential side effects?

There are generally no significant side effects expected from the interventions being tested as they involve non-invasive measures such as using PSAPs and participating in rehabilitation programs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe cognitive issues from conditions like stroke or Alzheimer's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measuring Change in International Outcome Inventory for Hearing Aids (IOI-HA) Outcomes

Measuring Change in the Hearing Handicap Inventory for Elderly (HHIE) Outcomes

Secondary study objectives

Measuring Change in Northwestern University-6 (NU-6) Word Recognition Outcomes

Measuring Change in Quick Speech In Noise (SIN) Word Recognition Outcomes

Measuring Change in the Abbreviated Profile of Hearing Aid Benefit (APHAB)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Audiology Best Practices plus Aural Rehabilitation (ABP+AR)Experimental Treatment3 Interventions

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.

Group II: Over-the-Counter Only (OTC-Only)Active Control2 Interventions

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.

Group III: Audiology Best Practices (ABP)Active Control2 Interventions

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.

0 / 2Eligibility criteria met