NCT07699146

Brief Summary

This study aims to assess the effectiveness of a Community Health Worker (CHW) delivered hearing loss intervention program (HEARS) for older adults in Maryland in collaboration with community organizations.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Nov 2026

Typical duration for not_applicable

Status
not yet recruiting

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 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

November 30, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

July 7, 2026

Last Update Submit

July 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Intervention feasibility (enrollment rate)

    Percentage of eligible individuals who enroll in the trial

    Baseline, 1-week, 3-months, and 6-months post-intervention

  • Intervention feasibility (intervention retention)

    Percentage of participants who complete the Hearing Handicap Inventory for the Elderly (HHIE-S)

    Baseline, 1-week, 3-months, and 6-months post-intervention

Secondary Outcomes (2)

  • Change in Hearing Handicap Inventory for the Elderly (HHIE-S)

    Baseline, 1-week, 3-months, and 6-months post-intervention

  • International Outcome Inventory for Hearing Aids (IOI-HA)

    Baseline, 1-week, 3-months, and 6-months post-intervention

Study Arms (1)

Immediate treatment

EXPERIMENTAL

HEARS Intervention

Device: HEARS MD DeviceBehavioral: HEARS MD Program

Interventions

Tailored fitting and programming of an over the counter hearing device accompanied by an aural rehabilitation component.

Immediate treatment

Tailored aural rehabilitation for participant.

Immediate treatment

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years or older
  • English-speaking
  • Aural-oral verbal communication as primary communication modality
  • Post-lingual hearing loss (Audiometric pure tone averages \[0.5-2kHz\] in better ear \>25 dB)

You may not qualify if:

  • Current self-reported use of hearing aid or amplification device
  • Medical contraindication to use hearing aids (e.g. draining ears)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing LossPresbycusis

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss, Sensorineural

Study Officials

  • Hae-Ra Han, PhD, RN

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carrie L Nieman, MD, MPH

CONTACT

Jalisa Bass

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start (Estimated)

November 30, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share