Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03442296
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 151
• Locations: 2
• Arms: 2
• Actual Duration (Months): 38.9
• Patients Per Site: 75.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Hearing Impairment 1; Personal Communication	Behavioral: Baltimore HEARS; Device: Baltimore HEARS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care
• Actual Study Start Date: Apr 18, 2018
• Actual Primary Completion Date: Jun 17, 2020
• Actual Study Completion Date: Jul 14, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Change From Baseline in Revised UCLA Loneliness Scale [Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)]

   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.

2. Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) [Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)]

   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.

3. 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.

4. Change From Baseline in Short Form -12 (SF-12) Physical 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 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.

5. 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.

6. Change From Baseline in Cohen Social Network Index (SNI): Social Network Size [Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)]

   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.

7. Change From Baseline in Valuation of Life [Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)]

   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.

8. Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy [Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)]

   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.

9. Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy [Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)]

   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.

10. Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest [Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)]

    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.

11. Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score [Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)]

    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.

12. Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening [Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)]

    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.

13. Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening [Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)]

    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.

14. Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet [Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)]

    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.

15. Change From Baseline in Hearing Knowledge [Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)]

    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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

29. 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.

30. 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.

31. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic Charities	Baltimore	Maryland	United States	21201
2	Weinberg Senior Living Communities	Baltimore	Maryland	United States	21215

Sponsors and Collaborators

• Johns Hopkins University
• National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: Frank R Lin, MD, PhD, Johns Hopkins University
• Study Director: Carrie L Nieman, MD, MPH, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol - Jul 9, 2021
• Statistical Analysis Plan - Aug 13, 2021

More Information

Additional Information:

• Description of HHIE - S measure

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.
• 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.
• 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.
• Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42.
• Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03442296
• Other Study ID Numbers: IRB00144968; R33DC015062-03
• First Posted: Feb 22, 2018
• Last Update Posted: Oct 14, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hearing Loss; Deafness

Study Results

Participant Flow

Recruitment Details	Study recruitment began in April 2018 and ended in October 2019. Participants were recruited from independent senior housing in Baltimore City and County and from Baltimore City senior centers and social centers.

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Period Title: 3 Month Follow-up
STARTED	78	73
COMPLETED	73	70
NOT COMPLETED	5	3
Period Title: 3 Month Follow-up
STARTED	58	52
COMPLETED	57	51
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group	Total
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	Total of all reporting groups
Overall Participants	78	73	151
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.1 (7.1)	78.2 (8.8)	77.1 (8)
Sex/Gender, Customized (Count of Participants)
Female	47 60.3%	54 74%	101 66.9%
Male	31 39.7%	17 23.3%	48 31.8%
NA	0 0%	2 2.7%	2 1.3%
Race/Ethnicity, Customized (Count of Participants)
Black	40 51.3%	25 34.2%	65 43%
Hispanic	1 1.3%	2 2.7%	3 2%
White Not Hispanic	37 47.4%	39 53.4%	76 50.3%
Other	0 0%	7 9.6%	7 4.6%
Living Arrangement (Count of Participants)
Does not live alone	25 32.1%	17 23.3%	42 27.8%
Lives Alone	53 67.9%	56 76.7%	109 72.2%
Education (Count of Participants)
High School or Equivalent	20 25.6%	22 30.1%	42 27.8%
Less than High School	21 26.9%	21 28.8%	42 27.8%
More than High School	37 47.4%	30 41.1%	67 44.4%
Monthly Household Income (Count of Participants)
Less than $25,000	48 61.5%	48 65.8%	96 63.6%
$25,000 to $49,999	16 20.5%	16 21.9%	32 21.2%
$50,000 to $74,999	7 9%	4 5.5%	11 7.3%
$75,000 to $99,999	2 2.6%	2 2.7%	4 2.6%
$100,000 to $149,999	0 0%	1 1.4%	1 0.7%
Don't Know	3 3.8%	1 1.4%	4 2.6%
Refused	2 2.6%	0 0%	2 1.3%
Skipped	0 0%	1 1.4%	1 0.7%
Montreal Cognitive Assessment (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	22.6 (4.4)	23.5 (3.9)	23 (4.2)
Speech-Frequency Pure Tone Average (db HL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [db HL]	41.5 (12.8)	42.6 (11.2)	42 (12)
Hearing Loss (Count of Participants)
Mild	43 55.1%	35 47.9%	78 51.7%
Moderate to severe	35 44.9%	38 52.1%	73 48.3%
Prior Hearing Aid Use (Count of Participants)
No prior Hearing Aid Use	66 84.6%	52 71.2%	118 78.1%
Prior Hearing Aid Use	11 14.1%	21 28.8%	32 21.2%
Don't Know	1 1.3%	0 0%	1 0.7%
HHIE-S (Hearing handicap inventory for the elderly - screening) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	21.7 (9.4)	20.1 (10.1)	21 (9.7)
UCLA Loneliness Scale (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	23.3 (10)	20.6 (9.2)	22 (9.7)
Patient Health Questionnaire - Depression Score (PHQ-9) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	6 (4.5)	5.9 (4.5)	6 (4.5)
Cohen Social Network Index (SNI): Network Diversity (number of roles) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of roles]	4.8 (1.9)	4.9 (1.7)	4.8 (1.8)
Cohen Social Network Index (SNI): Social Network Size (number of people) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [number of people]	17	15.5	16
12-Item Short Form Survey (SF-12): Mental Component Score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	48.5 (10.1)	49.4 (9.9)	49 (10)
12-Item Short Form Survey (SF-12) Physical Component Score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	39 (11)	39.4 (11.1)	39.2 (11)
Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	6.1 (1.7)	6.1 (1.8)	6.1 (1.8)
Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Computer Self Efficacy (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	19.3 (3.9)	19.1 (4.6)	19.2 (4.3)
Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.9 (1.8)	14.3 (1.8)	14.1 (1.8)
Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Self Efficacy (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	21.7 (2.3)	20.9 (3.1)	21.3 (2.7)
Own Smartphone (Count of Participants)
Doesn't own smartphone	36 46.2%	32 43.8%	68 45%
Owns smartphone	42 53.8%	40 54.8%	82 54.3%
NA	0 0%	1 1.4%	1 0.7%
Used Computer within past month (Count of Participants)
"I do not have or use a computer"	38 48.7%	38 52.1%	76 50.3%
"I have or use a computer but I do not go on the internet"	9 11.5%	6 8.2%	15 9.9%
"I have or use a computer and I used the internet"	31 39.7%	29 39.7%	60 39.7%
Used text or email within the past month (Count of Participants)
Most days	27 34.6%	24 32.9%	51 33.8%
Some days	8 10.3%	13 17.8%	21 13.9%
Rarely	10 12.8%	10 13.7%	20 13.2%
Not within the past month	33 42.3%	26 35.6%	59 39.1%
Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Total Score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	28.9 (10.3)	28.9 (9.1)	28.9 (9.7)
Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening Self- Efficacy (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	7.7 (4.9)	7.3 (4.7)	7.6 (4.8)
Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening Self-Efficacy (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	13.7 (4.5)	13.8 (4)	13.8 (4.2)
Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet Listening Self-Efficacy (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	7.4 (2.5)	7.7 (2.2)	7.6 (2.4)
Hearing Knowledge (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	3.3 (1.5)	3.4 (1.7)	3.4 (1.6)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

4 incomplete baseline measures (2 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 3 incomplete 3 month measures from immediate group

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	68	68
Mean (Standard Deviation) [score on a scale]	-13.2 (10.3)	.06 (7.1)

2. Secondary Outcome

Title	Change From Baseline in Revised UCLA Loneliness Scale
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

5 incomplete baseline measures (3 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 16 incomplete 3 month measures (11 immediate, 5 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	59	63
Mean (Standard Deviation) [score on a scale]	-2.8 (8.7)	-0.6 (7)

3. Secondary Outcome

Title	Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

8 incomplete baseline measures (3 immediate, 5 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 11 incomplete 3 month measures (9 immediate, 2 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	61	63
Mean (Standard Deviation) [score on a scale]	-1 (4.3)	-0.2 (4)

4. Secondary Outcome

Title	Change From Baseline in Short Form-12 (SF-12) Mental Component Score
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

6 incomplete baseline measures (3 immediate, 3 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	59	66
Mean (Standard Deviation) [score on a scale]	1.1 (11.2)	-1.4 (10)

5. Secondary Outcome

Title	Change From Baseline in Short Form -12 (SF-12) Physical Component Score
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

6 incomplete baseline measures (3 immediate, 3 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	59	66
Mean (Standard Deviation) [score on a scale]	4.4 (10.4)	-0.4 (10.1)

6. Secondary Outcome

Title	Change From Baseline in Cohen Social Network Index (SNI): Network Diversity
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

8 incomplete measures at baseline (5 immediate, 3 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 20 incomplete 3 month measures (14 immediate, 6 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	54	61
Mean (Standard Deviation) [number of roles]	0.3 (1.2)	-0.1 (1.2)

7. Secondary Outcome

Title	Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

8 incomplete baseline measures (5 immediate, 3 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 20 incomplete 3 month measures (14 immediate, 6 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	54	61
Mean (Standard Deviation) [number of individuals]	1.8 (6.9)	0.6 (6.2)

8. Secondary Outcome

Title	Change From Baseline in Valuation of Life
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

7 incomplete baseline measures (3 immediate, 4 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 11 incomplete 3 month measures (10 immediate, 1 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	60	65
Mean (Standard Deviation) [score on a scale]	0.1 (6.9)	-0.6 (5.1)

9. Secondary Outcome

Title	Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	62	69
Mean (Standard Deviation) [score on a scale]	-0.5 (3.8)	0 (3.2)

10. Secondary Outcome

Title	Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

3 incomplete baseline measures (1 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 10 incomplete 3 month measures from immediate group

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	62	68
Mean (Standard Deviation) [score on a scale]	-0.6 (3.8)	-0.1 (3.6)

11. Secondary Outcome

Title	Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
Description	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.
Time Frame	Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Outcome Measure Data

Analysis Population Description

1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 10 incomplete 3 month measures in immediate group

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	63	70
Mean (Standard Deviation) [score on a scale]	0.7 (2.3)	-0.4 (2.5)

12. Secondary Outcome

Title	Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
Description	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.
Time Frame	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

Outcome Measure Data

Analysis Population Description

2 incomplete baseline measures (2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	61	68
Mean (Standard Deviation) [score on a scale]	10.8 (11.3)	-0.7 (8.1)

13. Secondary Outcome

Title	Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
Description	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.
Time Frame	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

Outcome Measure Data

Analysis Population Description

1 incomplete baseline measures (1 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	61	69
Mean (Standard Deviation) [score on a scale]	5.1 (5.7)	-0.1 (4.3)

14. Secondary Outcome

Title	Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
Description	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.
Time Frame	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

Outcome Measure Data

Analysis Population Description

2 incomplete baseline measures (2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	61	68
Mean (Standard Deviation) [score on a scale]	4.2 (5.1)	-0.1 (4.5)

15. Secondary Outcome

Title	Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
Description	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.
Time Frame	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

Outcome Measure Data

Analysis Population Description

1 incomplete baseline measures (1 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	61	69
Mean (Standard Deviation) [score on a scale]	1.5 (2.7)	-0.6 (2.8)

16. Secondary Outcome

Title	Change From Baseline in Hearing Knowledge
Description	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.
Time Frame	Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

Outcome Measure Data

Analysis Population Description

9 incomplete baseline measures (5 immediate, 4 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 14 incomplete 3 month measures (12 immediate, 2 delayed)

Arm/Group Title	Immediate Treatment Group	Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.	3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Measure Participants	56	64
Mean (Standard Deviation) [score on a scale]	0.2 (1.6)	-0.4 (1.5)

17. Secondary Outcome

Title	Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

18. Secondary Outcome

Title	Change From Baseline in Revised UCLA Loneliness Scale
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

19. Secondary Outcome

Title	Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

20. Secondary Outcome

Title	Change From Baseline in Short Form -12 (SF-12) Mental Component Score
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

21. Secondary Outcome

Title	Change From Baseline in Short Form -12 (SF-12) Physical Component Score
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

22. Secondary Outcome

Title	Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

23. Secondary Outcome

Title	Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

24. Secondary Outcome

Title	Change From Baseline in Valuation of Life
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

25. Secondary Outcome

Title	Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

26. Secondary Outcome

Title	Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

27. Secondary Outcome

Title	Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

28. Secondary Outcome

Title	Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

29. Secondary Outcome

Title	Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

30. Secondary Outcome

Title	Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

31. Secondary Outcome

Title	Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

32. Secondary Outcome

Title	Change From Baseline in Hearing Knowledge
Description	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.
Time Frame	Baseline and 12 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse event data for each participant is collected from Screening to 12 Month Post-Intervention Visit (up to 2 years)
Arm/Group Title	Immediate Treatment Group		Delayed Treatment Group
Arm/Group Description	Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.		3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
All Cause Mortality
	Immediate Treatment Group		Delayed Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/78 (7.7%)		4/73 (5.5%)
Serious Adverse Events
	Immediate Treatment Group		Delayed Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/78 (0%)		0/73 (0%)
Other (Not Including Serious) Adverse Events
	Immediate Treatment Group		Delayed Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/78 (0%)		0/73 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.