Hearing Healthcare Assessment in Rural Communities (HHARC)

April 16, 2024 updated by: Matthew Bush, MD

Hearing Healthcare Assessment in Rural Communities (HHARC)

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 years or older)
  • Able to speak, understand, and read English.

Exclusion Criteria:

-Under 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Receiving a Diagnostic Audiogram After Enrollment
Time Frame: From Enrollment to Study Completion at 12 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthew Bush, MD

Collaborators

National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Matthew L Bush, M.D., University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65361
  • R33DC019602 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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