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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
First received
Last updated
Start date June 1, 2024
Est. completion date July 31, 2026

Study information

Verified date May 2024
Source University of Kentucky
Contact Matthew L Bush, M.D.
Phone 859-218-2167
Email matthew.bush@uky.edu
Is FDA regulated No
Health authority
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 31, 2026
Est. primary completion date July 31, 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

Study Design


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
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