Hearing Program in Primary Care

December 31, 2025 updated by: NYU Langone Health

Feasibility of a Hearing Program in Primary Care for Underserved Older Adults

During a primary care visit, investigators will screen and identify participants with hearing loss and then randomize to a) counseling on accessible assistive listening devices or b) referral to traditional audiology care pathway alone.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYC H+H/Bellevue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • speaks English or Spanish;
  • capacity to consent to research

Exclusion Criteria:

• has or uses hearing aids or cochlear implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alternative Rehabilitation Strategies
Patients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm.
Behavioral: Alternative rehabilitation strategies
Counseling intervention.
Active Comparator: Usual Care
Patients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone.
Behavioral: Usual Care
Usual care audiology pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Potential Participants Approached
Time Frame: Up to Month 3
Up to Month 3
Number of Potential Participants Screened
Time Frame: Up to Month 3
Up to Month 3
Percentage of Screened Participants with Hearing Loss
Time Frame: Up to Month 3
Up to Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Intervention Arm Participants who Complete Counseling Session
Time Frame: Up to Month 3
Up to Month 3
Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours
Time Frame: Up to Month 3
Up to Month 3
Percentage of Participants who Respond to 3-Month Follow-Up
Time Frame: Month 3
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: David Friedmann, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

January 15, 2026

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-00648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.friedmann@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.friedmann@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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