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Active, not recruitingNCT05786794HHARCUpdated Aug 20, 2026

Hearing Healthcare Assessment in Rural Communities

An interventional study of Patient Navigation Program for Hearing Health Care in Hearing Loss, Adult-Onset and Hearing Loss, Age-Related, sponsored by Matthew Bush, MD. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Matthew Bush, MD · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Adult hearing loss in is the third most common chronic health condition in the United States. Adults living in rural areas face a higher risk of experiencing hearing loss, and more difficulty receiving testing and treatment than adults in urban settings. The goal of this clinical trial is to develop and test a community-based hearing healthcare patient navigation program in rural Kentucky. The main question this study aims to answer is:

-Can the number of rural adults receiving diagnostic hearing tests be increased?

Read the detailed description

Investigators will pilot test the rural hearing health care patient navigation program (N=500 patients from 10 rural clinics). The program will be evaluated with the following outcome: number of participants obtaining a diagnostic audiogram within past 12 months after enrollment among rural adults

02

Conditions studied

  • Hearing Loss, Adult-Onset
  • Hearing Loss, Age-Related

Keywords

  • Patient Navigator
  • Adult Hearing Screening
  • Adult Hearing Loss
03

In context

Hearing Loss

796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.

This study's planned enrollment of 500 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Matthew Bush, MD is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • Able to speak, understand, and read English.
  • Patient of a participating primary care clinic

Exclusion criteria

Exclusion Criteria:

-Under 18

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Rural Clinic Hearing Healthcare Patient Navigation Program

    This arm will involve pilot testing of the Patient Navigation Program with adults in rural primary care clinics

    Behavioral: Patient Navigation Program for Hearing Health Care

Interventions

  • BehavioralPatient Navigation Program for Hearing Health Care

    Patients presenting for routine office visits will be invited to participate in the study and informed consent procedures and study enrollment will be conducted by a research assistant. Participants will then undergo baseline assessment. Following baseline measures, participants who screen positive for hearing loss will be contacted by the Patient Navigator (PN) to begin the intervention. The navigator will contact participants every 2 weeks to focus on addressing key aspects of Hearing Health Care (HHC): education, screening, diagnosis, and treatment. PNs will assist the patient to undergo a formal audiogram with the 12 months following enrollment. Each PN session will likely last between 10-30 minutes. Post-intervention data collection also administered by a trained interviewer, will occur following a diagnostic audiogram with an audiologist or at 12 months following enrollment.

06

What researchers measure

Primary outcomes

  1. Number of Participants Receiving a Diagnostic Audiogram After Enrollment

    Participants will be assisted to reduce barriers in scheduling a diagnostic audiogram within 12 months following enrollment

    Time frame: From Enrollment to Study Completion at 12 Months

07

Study locations

9 sites
  • One Cross Medical Clinic
    Campbellsville, Kentucky 42718, United States
  • United Clinics of Kentuck
    Campton, Kentucky 41301, United States
  • Blount Rural Health Center
    Elkton, Kentucky 42220, United States
  • North Fork Valley Community Health
    Hazard, Kentucky 41339, United States
  • Primary Care Centers of Eastern Kentucky
    Hazard, Kentucky 41701, United States
  • Estill Medical Clinic
    Irvine, Kentucky 40336, United States
  • Juniper Health
    Jackson, Kentucky 41339, United States
  • United Clinics of Kentucky
    Jackson, Kentucky 41339, United States
  • University of Kentucky Department of Otolaryngology
    Lexington, Kentucky 40536, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Jul 2027, 35 months after the start.

Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 35 months is above that.

Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2023
First posted
Mar 28, 2023
StartActual
Aug 8, 2024
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05786794
Lead sponsor
Matthew Bush, MD
Responsible party
Matthew Bush, MD (Professor, University of Kentucky) — Sponsor-investigator
First posted
Mar 28, 2023
Start date
Aug 8, 2024
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Matthew L Bush, M.D.
principal investigator · University of Kentucky

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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