Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions

Not Applicable

Completed

Conditions: Age-related Hearing Impairment 1
Personal Communication

Interventions: Device: Baltimore HEARS

Registration Number: NCT03442296

Lead Sponsor: Johns Hopkins University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Treatment Group	Baltimore HEARS	3-month delayed treatment with Baltimore HEARS intervention
Immediate Treatment Group	Baltimore HEARS	Immediate treatment with Baltimore HEARS intervention

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)	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 Outcome Measures

Name	Time	Method
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 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.
Change From Baseline in Revised UCLA Loneliness Scale	Baseline and 12 months post-intervention	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.
Change From Baseline in Short Form -12 (SF-12) Physical Component Score	Baseline and 12 months post-intervention	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.
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening	Baseline and 12 months post-intervention	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.
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet	Baseline and 12 months post-intervention	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.
Change From Baseline in Short Form -12 (SF-12) Mental Component Score	Baseline and 12 months post-intervention	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.
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy	Baseline and 12 months post-intervention	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.
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy	Baseline and 12 months post-intervention	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.
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest	Baseline and 12 months post-intervention	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.
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening	Baseline and 12 months post-intervention	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.
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)	Baseline and 12 months post-intervention	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.
Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity	Baseline and 12 months post-intervention	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.
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)	Baseline and 12 months post-intervention	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.
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score	Baseline and 12 months post-intervention	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.
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)	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.
Change From Baseline in Hearing Knowledge	Baseline and 12 months post-intervention	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.
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size	Baseline and 12 months post-intervention	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.
Change From Baseline in Valuation of Life	Baseline and 12 months post-intervention	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.