Adults 60 to 100, any sex, with Age-related Hearing Impairment 1 or Personal Communication. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)Primary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap.
Scoring:
0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Group
Value
95% CI
Immediate Treatment Group
-13.2
± 10.3
Delayed Treatment Group
.06
± 7.1
Change From Baseline in Revised UCLA Loneliness ScaleSecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Measure was collected via a one-on-one interview conducted by a trained data collector.
Score is the sum of 20-item self-reported measure. Scores range from 20 to 80.
Score ranges:
20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness.
Group
Value
95% CI
Immediate Treatment Group
-2.8
± 8.7
Delayed Treatment Group
-0.6
± 7
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)Secondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Measure collected via one-on-one interview conducted by trained data collectors.
Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27.
Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity.
Group
Value
95% CI
Immediate Treatment Group
-1
± 4.3
Delayed Treatment Group
-0.2
± 4
Change From Baseline in Short Form-12 (SF-12) Mental Component ScoreSecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.
The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Group
Value
95% CI
Immediate Treatment Group
1.1
± 11.2
Delayed Treatment Group
-1.4
± 10
Change From Baseline in Short Form -12 (SF-12) Physical Component ScoreSecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.
The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Group
Value
95% CI
Immediate Treatment Group
4.4
± 10.4
Delayed Treatment Group
-0.4
± 10.1
Change From Baseline in Cohen Social Network Index (SNI): Network DiversitySecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the score from baseline (a positive number) indicates a more diverse network.
Group
Value
95% CI
Immediate Treatment Group
0.3
± 1.2
Delayed Treatment Group
-0.0
± 1.2
Change From Baseline in Cohen Social Network Index (SNI): Social Network SizeSecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size.
Group
Value
95% CI
Immediate Treatment Group
1.8
± 10.5
Delayed Treatment Group
1.0
± 7.2
Change From Baseline in Valuation of LifeSecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life.
Group
Value
95% CI
Immediate Treatment Group
0.1
± 6.9
Delayed Treatment Group
-0.6
± 5.1
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-EfficacySecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Group
Value
95% CI
Immediate Treatment Group
-0.5
± 3.8
Delayed Treatment Group
0
± 3.2
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-EfficacySecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Group
Value
95% CI
Immediate Treatment Group
-0.6
± 3.8
Delayed Treatment Group
-0.1
± 3.6
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device InterestSecondary· Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Group
Value
95% CI
Immediate Treatment Group
0.7
± 2.3
Delayed Treatment Group
-0.4
± 2.5
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total ScoreSecondary· Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Group
Value
95% CI
Immediate Treatment Group
10.8
± 11.3
Delayed Treatment Group
-0.7
± 8.1
Sponsor's own description
Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 4 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03442296.