Hearing Healthcare Assessment in Rural Communities (HHARC)
Primary Purpose
Hearing Loss, Adult-Onset, Hearing Loss, Age-Related
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient Navigation Program for Hearing Health Care
Sponsored by
About this trial
This is an interventional diagnostic trial for Hearing Loss, Adult-Onset focused on measuring Patient Navigator, Adult Hearing Screening, Adult Hearing Loss
Eligibility Criteria
Inclusion Criteria: Age 18 years or older) Able to speak, understand, and read English. Exclusion Criteria: -Under 18
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rural Clinic Hearing Healthcare Patient Navigation Program
Arm Description
This arm will involve pilot testing of the Patient Navigation Program with adults in rural primary care clinics
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05786794
First Posted
March 14, 2023
Last Updated
August 24, 2023
Sponsor
Matthew Bush, MD
Collaborators
National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT05786794
Brief Title
Hearing Healthcare Assessment in Rural Communities
Acronym
HHARC
Official Title
Hearing Healthcare Assessment in Rural Communities (HHARC)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2024 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew Bush, MD
Collaborators
National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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?
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Adult-Onset, Hearing Loss, Age-Related
Keywords
Patient Navigator, Adult Hearing Screening, Adult Hearing Loss
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rural Clinic Hearing Healthcare Patient Navigation Program
Arm Type
Experimental
Arm Description
This arm will involve pilot testing of the Patient Navigation Program with adults in rural primary care clinics
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation Program for Hearing Health Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Receiving a Diagnostic Audiogram After Enrollment
Description
Participants will be assisted to reduce barriers in scheduling a diagnostic audiogram within 12 months following enrollment
Time Frame
From Enrollment to Study Completion at 12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older)
Able to speak, understand, and read English.
Exclusion Criteria:
-Under 18
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew L Bush, M.D.
Phone
859-218-2167
Email
matthew.bush@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew L Bush, M.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hearing Healthcare Assessment in Rural Communities
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