Hearing Loss, Adult-OnsetHHARCNCT05786794
Hearing Healthcare Assessment in Rural Communities
A study testing Patient Navigation Program for Hearing Health Care in people with Hearing Loss, Adult-Onset and Hearing Loss, Age-Related, run by Matthew Bush, MD at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Adult-Onset, Hearing Loss, Age-Related
- What is being tested?
- Patient Navigation Program for Hearing Health Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 9 sitesUnited States
- Study dates
- 8 Aug 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able to speak, understand, and read English.
- Patient of a participating primary care clinic
Who cannot join
- -Under 18
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
One Cross Medical Clinic
Campbellsville, Kentucky, 42718
United Clinics of Kentuck
Campton, Kentucky, 41301
Blount Rural Health Center
Elkton, Kentucky, 42220
North Fork Valley Community Health
Hazard, Kentucky, 41339
Primary Care Centers of Eastern Kentucky
Hazard, Kentucky, 41701
Estill Medical Clinic
Irvine, Kentucky, 40336
Juniper Health
Jackson, Kentucky, 41339
United Clinics of Kentucky
Jackson, Kentucky, 41339
University of Kentucky Department of Otolaryngology
Lexington, Kentucky, 40536
About this study
Official title: Hearing Healthcare Assessment in Rural Communities (HHARC)
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?
Read the 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
- Being tested
- Patient Navigation Program for Hearing Health Care
- Keywords
- Patient Navigator, Adult Hearing Screening, Adult Hearing Loss
- Medical subject headings
- Hearing Loss, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation Program for Hearing Health CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Rural Clinic Hearing Healthcare Patient Navigation Program | Experimental | This arm will involve pilot testing of the Patient Navigation Program with adults in rural primary care clinics Receives: Behavioral: Patient Navigation Program for Hearing Health Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Enrollment to Study Completion at 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start8 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Adult-OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Bush, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Matthew Bush, MD, University of Kentucky
- Investigators
- Matthew L Bush, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786794
- Sponsor's protocol ID
- 65361
- Other IDs
- R33DC019602
- Acronym
- HHARC
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Healthcare Assessment in Rural Communities (HHARC)
- ClinicalTrials.gov ID
- NCT05786794
- Acronym / sponsor ID
- HHARC / 65361
- Keywords
- Patient Navigator, Adult Hearing Screening, Adult Hearing Loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Matthew Bush, MDUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rural Clinic Hearing Healthcare Patient Navigation Program | Experimental | Behavioral: Patient Navigation Program for Hearing Health CareThis arm will involve pilot testing of the Patient Navigation Program with adults in rural primary care clinics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Able to speak, understand, and read English.
- Patient of a participating primary care clinic
Key exclusion criteria (1 listed)
- -Under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Navigation Program for Hearing Health CarePatients 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. | Behavioural | Rural Clinic Hearing Healthcare Patient Navigation Program |
Primary outcome
Number of Participants Receiving a Diagnostic Audiogram After Enrollment
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew L Bush, M.D. principal investigator
University of Kentucky
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation Program for Hearing Health Care in people with Hearing Loss, Adult-Onset and Hearing Loss, Age-Related, run by Matthew Bush, MD at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Receiving a Diagnostic Audiogram After Enrollment (time frame: From Enrollment to Study Completion at 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.