N/A
Completed N=15
The Baltimore HEARS Pilot Study
Age-related Hearing Impairment 1 · Personal Communication
Source: ClinicalTrials.gov NCT02045511 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months — -8.5; 0.3 units on a scale
Summary
The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months |
-8.5; 0.3 | — |
| SECONDARY Change From Baseline in Revised QDS at 3 Months |
-5.9; -2.1 | — |
| SECONDARY Change From Baseline in Revised UCLA at 3 Months |
-2.1; -4 | — |
| SECONDARY Change From Baseline in PHQ-9 at 3 Months |
-4.4; -1 | — |
| SECONDARY Change From Baseline in SF-36 Mental Component at 3 Months |
2.1; 1.7 | — |
| SECONDARY Change From Baseline in SF-36 Physical Component at 3 Months |
3.6; -1.3 | — |
Eligibility Criteria
Inclusion Criteria
- Age 60 years or older
- English-speaking
- Aural-oral verbal communication as primary communication modality
- Post-lingual hearing loss
- Does not currently use a hearing amplification device or hearing aid
- Signed informed consent to participate in baseline, 1 month, and 3 month assessments
- Have a communication partner able to accompany them to all study-related appointments
Exclusion Criteria
- Individuals who do not fulfill inclusion criteria
- Score ≤ 25 on the Montreal Cognitive Assessment
Data sourced from ClinicalTrials.gov (NCT02045511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.