Hearing Healthcare Assessment in Rural Communities

NCT05786794 | Recruiting

• 2 other identifiers: 65361R33DC019602
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 9

Brief 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?

Conditions

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

Keywords

Patient Navigator; Adult Hearing Screening; Adult Hearing Loss

Outcome Measures

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

  From Enrollment to Study Completion at 12 Months

Study Arms (1)

Rural Clinic Hearing Healthcare Patient Navigation Program

EXPERIMENTAL

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

Patient Navigation Program for Hearing Health Care 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.

Rural Clinic Hearing Healthcare Patient Navigation Program

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Under 18

Sponsors & Collaborators

• Matthew Bush, MD: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (9)

One Cross Medical Clinic

Campbellsville, Kentucky, 42718, United States

RECRUITING

United Clinics of Kentuck

Campton, Kentucky, 41301, United States

RECRUITING

Blount Rural Health Center

Elkton, Kentucky, 42220, United States

RECRUITING

North Fork Valley Community Health

Hazard, Kentucky, 41339, United States

RECRUITING

Primary Care Centers of Eastern Kentucky

Hazard, Kentucky, 41701, United States

RECRUITING

Estill Medical Clinic

Irvine, Kentucky, 40336, United States

RECRUITING

Juniper Health

Jackson, Kentucky, 41339, United States

RECRUITING

United Clinics of Kentucky

Jackson, Kentucky, 41339, United States

RECRUITING

University of Kentucky Department of Otolaryngology

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss; Presbycusis

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Matthew L Bush, M.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew L Bush, M.D.

CONTACT

859-218-2167; matthew.bush@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 28, 2023
• Study Start: August 8, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)