Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Age-related Hearing Impairment 1
- Sponsor
- Johns Hopkins University
- Enrollment
- 151
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 60 years or older
- •English-speaking
- •Aural-oral verbal communication as primary communication modality
- •Post-lingual hearing loss (Audiometric pure tone averages \[0.5-4kHz\] in both ears \>25 dB)
- •Does not currently use a hearing amplification device or hearing aid
- •Signed informed consent to participate in all study related activities
- •Willing to regularly use listening device once provided for the remainder of their time in the study
- •Hearing handicap as measured by HHIE-S score \>8
- •Able to follow study instructions
Exclusion Criteria
- •Individuals who do not fulfill inclusion criteria
- •Evidence of ear disease or pathology requiring further medical evaluation
Outcomes
Primary Outcomes
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Time Frame: 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.
Secondary Outcomes
- Change From Baseline in Cohen Social Network Index (SNI): Network Diversity(Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group))
- Change From Baseline in Revised UCLA Loneliness Scale(Baseline and 12 months post-intervention)
- Change From Baseline in Short Form -12 (SF-12) Physical Component Score(Baseline and 12 months post-intervention)
- Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening(Baseline and 12 months post-intervention)
- Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet(Baseline and 12 months post-intervention)
- Change From Baseline in Short Form -12 (SF-12) Mental Component Score(Baseline and 12 months post-intervention)
- Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy(Baseline and 12 months post-intervention)
- Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy(Baseline and 12 months post-intervention)
- Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest(Baseline and 12 months post-intervention)
- Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening(Baseline and 12 months post-intervention)
- Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)(Baseline and 12 months post-intervention)
- Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity(Baseline and 12 months post-intervention)
- Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)(Baseline and 12 months post-intervention)
- Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score(Baseline and 12 months post-intervention)
- Change From Baseline in Short Form-12 (SF-12) Mental Component Score(Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group))
- Change From Baseline in Hearing Knowledge(Baseline and 12 months post-intervention)
- Change From Baseline in Cohen Social Network Index (SNI): Social Network Size(Baseline and 12 months post-intervention)
- Change From Baseline in Valuation of Life(Baseline and 12 months post-intervention)