Hearing Program in Primary Care

Deafness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943509
• Other study ID #: 23-00648
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: David Friedmann
• Phone: 212 263 6344
• Email: David.friedmann[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• speaks English or Spanish;

• capacity to consent to research

Exclusion Criteria:

• has or uses hearing aids or cochlear implants

Related Conditions & MeSH terms

• Deafness

Intervention

Behavioral:
• Alternative rehabilitation strategies
Counseling intervention.
• Usual Care
Usual care audiology pathway.

Locations

Country	Name	City	State
United States	NYC H+H/Bellevue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Potential Participants Approached		Up to Month 3
Primary	Number of Potential Participants Screened		Up to Month 3
Primary	Percentage of Screened Participants with Hearing Loss		Up to Month 3
Secondary	Percentage of Intervention Arm Participants who Complete Counseling Session		Up to Month 3
Secondary	Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours		Up to Month 3
Secondary	Percentage of Participants who Respond to 3-Month Follow-Up		Month 3