Hearing Program in Primary Care

Sponsor

NYU Langone Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05943509

Collaborator

(none)

120

Enrollment

Location

Arms

21.9

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deafness	Behavioral: Alternative rehabilitation strategies Behavioral: Usual Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

speaks English or Spanish;
capacity to consent to research

Exclusion Criteria:

• has or uses hearing aids or cochlear implants

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYC H+H/Bellevue	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: David Friedmann, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT05943509

Other Study ID Numbers:

23-00648

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 13, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

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

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

Additional relevant MeSH terms:

Deafness

Study Results

No Results Posted as of Jul 13, 2023