Hearing Healthcare Assessment in Rural Communities

NCT ID: NCT05786794

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-08

Study Completion Date

2026-07-31

Brief Summary

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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?

Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Approximately 500 patients from 10 rural clinics will be recruited to participate in the trial. All participants will complete baseline surveys and eligible candidates will engage with a Patient Navigator who will assist them in overcoming specific barriers to obtain a diagnostic audiogram with an audiologist.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Patient Navigation Program for Hearing Health Care

Intervention Type BEHAVIORAL

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.

Interventions

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Patient 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Under 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Matthew Bush, MD

OTHER

Sponsor Role lead

Responsible Party

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Matthew Bush, MD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Matthew L Bush, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky Department of Otolaryngology

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew L Bush, M.D.

Role: CONTACT

859-218-2167

Facility Contacts

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Matthew Bush

Role: primary

Matthew L Bush

Role: backup

Other Identifiers

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R33DC019602

Identifier Type: NIH

Identifier Source: secondary_id

View Link

65361

Identifier Type: -

Identifier Source: org_study_id

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