Clinical trial NCT03442296: Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions
Official title: Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Hearing Impairment 1
Personal Communication
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-02-22
Enrollment: 151
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Secondary outcomes:
measure: Change From Baseline in Revised UCLA Loneliness Scale
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Short Form-12 (SF-12) Mental Component Score
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Short Form -12 (SF-12) Physical Component Score
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Cohen Social Network Index (SNI): Network Diversity
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Valuation of Life
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
timeFrame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
measure: Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
timeFrame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
measure: Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
timeFrame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
measure: Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
timeFrame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
measure: Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
timeFrame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
measure: Change From Baseline in Hearing Knowledge
timeFrame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
measure: Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Revised UCLA Loneliness Scale
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Short Form -12 (SF-12) Mental Component Score
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Short Form -12 (SF-12) Physical Component Score
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Valuation of Life
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
timeFrame: Baseline and 12 months post-intervention
measure: Change From Baseline in Hearing Knowledge
timeFrame: Baseline and 12 months post-intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Catholic Charities
state: Maryland
city: Baltimore
country: United States
facility: Weinberg Senior Living Communities
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Frank R Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Carrie L Nieman, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
citation: Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
citation: Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011.
citation: Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
citation: Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
citation: Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.