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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
Matthew Bush, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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)
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    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

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    Hearing Healthcare Assessment in Rural Communities

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