HHARC: Hearing Healthcare Assessment in Rural Communities

Sponsor

Matthew Bush, MD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05786794

Collaborator

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

500

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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 we increase the number of rural adults receiving diagnostic hearing tests?

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Adult-Onset Hearing Loss, Age-Related	Behavioral: Patient Navigation Program for Hearing Health Care	N/A

Detailed Description

Investigators will pilot test the rural hearing health care patient navigation program (N=500 patients from 10 RHCs). We will evaluate the program with the following outcome: number of participants obtaining a diagnostic audiogram within past 12 months after enrollment among rural adults

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Approximately 500 patients from 10 Rural Health Clinics will be recruited to participate in the trial. All participants will complete baseline surveys and will engage with a Patient Navigator who will guide patients through app-based Mimi hearing screening test, and assist patients in overcoming specific barriers to obtain a diagnostic audiogram with an audiologist.Approximately 500 patients from 10 Rural Health Clinics will be recruited to participate in the trial. All participants will complete baseline surveys and will engage with a Patient Navigator who will guide patients through app-based Mimi hearing screening test, and assist patients in overcoming specific barriers to obtain a diagnostic audiogram with an audiologist.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Hearing Healthcare Assessment in Rural Communities (HHARC)

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RHC Hearing Healthcare Patient Navigation Program This arm will involve pilot testing of the Patient Navigation Program with adults in Rural Health Centers(RHCs).	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. Approximately one week later, patients will be contacted by the Patient Navigator (PN) and begin the intervention. The navigator will contact patients every 2 weeks to focus on addressing key aspects of Hearing Health Care (HHC): education, screening, diagnosis, and treatment. PNs will guide the patient through a free smartphone enabled app-based Mimi© hearing screening testing. Based on those results, 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.

Arm

Intervention/Treatment

Experimental: RHC Hearing Healthcare Patient Navigation Program

This arm will involve pilot testing of the Patient Navigation Program with adults in Rural Health Centers(RHCs).

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. Approximately one week later, patients will be contacted by the Patient Navigator (PN) and begin the intervention. The navigator will contact patients every 2 weeks to focus on addressing key aspects of Hearing Health Care (HHC): education, screening, diagnosis, and treatment. PNs will guide the patient through a free smartphone enabled app-based Mimi© hearing screening testing. Based on those results, 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.

Outcome Measures

Primary Outcome Measures

Number of Participants Receiving a Diagnostic Audiogram After Enrollment [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

-Under 18

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Matthew Bush, MD
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matthew Bush, MD, Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT05786794

Other Study ID Numbers:

65361

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Matthew Bush, MD, Professor, University of Kentucky

Patient Navigator

Adult Hearing Screening

Adult Hearing Loss

Additional relevant MeSH terms:

Hearing Loss

Deafness

Presbycusis

Study Results

No Results Posted as of Mar 28, 2023