Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions

Study 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.

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

Conditions
-----------------
Age-related Hearing Impairment 1, Personal Communication

Intervention / Treatment
-----------------
* Behavioral: Baltimore HEARS
* Device: Baltimore HEARS


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 |