Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternative Rehabilitation Strategies | Experimental | Patients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm. |
|
| Usual Care | Active Comparator | Patients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternative rehabilitation strategies | Behavioral | Counseling intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• has or uses hearing aids or cochlear implants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Friedmann | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYC H+H/Bellevue | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41736137 | Derived | 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;12(1):68. doi: 10.1186/s40814-026-01773-2. |
Not provided
Not provided
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2023 | Dec 31, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003638 | Deafness |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual Care | Behavioral | Usual care audiology pathway. |
|
| Percentage of Participants who Respond to 3-Month Follow-Up | Month 3 |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |