Hearing Healthcare Assessment in Rural Communities

Hearing Loss, Age-Related Clinical Trial

— HHARC  

Official title:

Hearing Healthcare Assessment in Rural Communities (HHARC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05786794
• Other study ID #: 65361
• Secondary ID: R33DC019602
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: Matthew L Bush, M.D.
• Phone: 859-218-2167
• Email: matthew.bush[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older)
• Able to speak, understand, and read English. Exclusion Criteria: -Under 18

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Age-Related
• Presbycusis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Matthew Bush, MD	National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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