Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions (HEARS)

Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care

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.

Study Overview

• Status: Completed
• Conditions: Personal Communication; Age-related Hearing Impairment 1
• Intervention / Treatment: Behavioral: Baltimore HEARS; Device: Baltimore HEARS

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Catholic Charities
    • Baltimore, Maryland, United States, 21215
      • Weinberg Senior Living Communities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Immediate Treatment Group; Immediate treatment with Baltimore HEARS intervention	Behavioral: Baltimore HEARS; Tailored aural rehabilitation for participant and communication partner (if applicable); Device: Baltimore HEARS; Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
PLACEBO_COMPARATOR: Delayed Treatment Group; 3-month delayed treatment with Baltimore HEARS intervention	Behavioral: Baltimore HEARS; Tailored aural rehabilitation for participant and communication partner (if applicable); Device: Baltimore HEARS; Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Revised UCLA Loneliness Scale	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Short Form-12 (SF-12) Mental Component Score	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Short Form -12 (SF-12) Physical Component Score	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Cohen Social Network Index (SNI): Network Diversity	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Valuation of Life	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest	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.	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score	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.	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening	This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening	This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet	This measure is a participant's self-reported listening self efficacy on a 0-10 score scale in a dialog in quiet listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Hearing Knowledge	This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. The score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge.	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)	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.	Baseline and 12 months post-intervention
Change From Baseline in Revised UCLA Loneliness Scale	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.	Baseline and 12 months post-intervention
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)	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.	Baseline and 12 months post-intervention
Change From Baseline in Short Form -12 (SF-12) Mental Component Score	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.	Baseline and 12 months post-intervention
Change From Baseline in Short Form -12 (SF-12) Physical Component Score	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.	Baseline and 12 months post-intervention
Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity	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 number of roles from baseline (a positive number) indicates a more diverse network.	Baseline and 12 months post-intervention
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size	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.	Baseline and 12 months post-intervention
Change From Baseline in Valuation of Life	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.	Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy	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.	Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy	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.	Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest	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.	Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score	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.	Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening	This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.	Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening	This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in directed listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.	Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet	This measure is a participant's self-reported listening self efficacy on a 0-10 scale in a directed listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.	Baseline and 12 months post-intervention
Change From Baseline in Hearing Knowledge	This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. Score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge.	Baseline and 12 months post-intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Study Director: Carrie L Nieman, MD, MPH, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
• Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
• 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.
• 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.
• 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.

Helpful Links

• Description of HHIE - S measure

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2018
• Primary Completion (ACTUAL): June 17, 2020
• Study Completion (ACTUAL): July 14, 2021

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (ACTUAL): February 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: IRB00144968; R33DC015062-03 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No