Hearing Program in Primary Care
Feasibility of a Hearing Program in Primary Care for Underserved Older Adults
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedStudy Start
First participant enrolled
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2026
CompletedJanuary 6, 2026
December 1, 2025
1.9 years
July 5, 2023
December 31, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Potential Participants Approached
Up to Month 3
Number of Potential Participants Screened
Up to Month 3
Percentage of Screened Participants with Hearing Loss
Up to Month 3
Secondary Outcomes (3)
Percentage of Intervention Arm Participants who Complete Counseling Session
Up to Month 3
Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours
Up to Month 3
Percentage of Participants who Respond to 3-Month Follow-Up
Month 3
Study Arms (2)
Alternative Rehabilitation Strategies
EXPERIMENTALPatients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm.
Usual Care
ACTIVE COMPARATORPatients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone.
Interventions
Counseling intervention.
Eligibility Criteria
You may qualify if:
- speaks English or Spanish;
- capacity to consent to research
You may not qualify if:
- has or uses hearing aids or cochlear implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYC H+H/Bellevue
New York, New York, 10016, United States
Related Publications (1)
Friedmann DR, Diminich LN, Spitzer ER, Ajmal S, Weinstein B, Dickson V, Goldfeld KS, Chodosh J. Study protocol: feasibility of a hearing program in primary care for underserved older adults. Pilot Feasibility Stud. 2026 Feb 24. doi: 10.1186/s40814-026-01773-2. Online ahead of print.
PMID: 41736137DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Friedmann
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2023
First Posted
July 13, 2023
Study Start
February 15, 2024
Primary Completion
January 15, 2026
Study Completion
January 15, 2026
Last Updated
January 6, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.