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Hearing Program in Primary Care

Primary Purpose

Deafness

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alternative rehabilitation strategies
Usual Care
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: speaks English or Spanish; capacity to consent to research Exclusion Criteria: • has or uses hearing aids or cochlear implants

Sites / Locations

  • NYC H+H/Bellevue

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alternative Rehabilitation Strategies

Usual Care

Arm Description

Patients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm.

Patients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone.

Outcomes

Primary Outcome Measures

Number of Potential Participants Approached
Number of Potential Participants Screened
Percentage of Screened Participants with Hearing Loss

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2023
Last Updated
July 5, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05943509
Brief Title
Hearing Program in Primary Care
Official Title
Feasibility of a Hearing Program in Primary Care for Underserved Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alternative Rehabilitation Strategies
Arm Type
Experimental
Arm Description
Patients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone.
Intervention Type
Behavioral
Intervention Name(s)
Alternative rehabilitation strategies
Intervention Description
Counseling intervention.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual care audiology pathway.
Primary Outcome Measure Information:
Title
Number of Potential Participants Approached
Time Frame
Up to Month 3
Title
Number of Potential Participants Screened
Time Frame
Up to Month 3
Title
Percentage of Screened Participants with Hearing Loss
Time Frame
Up to Month 3
Secondary Outcome Measure Information:
Title
Percentage of Intervention Arm Participants who Complete Counseling Session
Time Frame
Up to Month 3
Title
Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours
Time Frame
Up to Month 3
Title
Percentage of Participants who Respond to 3-Month Follow-Up
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: speaks English or Spanish; capacity to consent to research Exclusion Criteria: • has or uses hearing aids or cochlear implants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Friedmann
Phone
212 263 6344
Email
David.friedmann@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Montella
Phone
212 263 6344
Email
Kristin.montella@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Friedmann
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYC H+H/Bellevue
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Hearing Program in Primary Care

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