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

• ClinicalTrials.gov Identifier: NCT03442296
• Recruitment Status: Completed
• First Posted: February 22, 2018
• Results First Posted: October 14, 2021
• Last Update Posted: October 14, 2021
• Sponsor: Johns Hopkins University
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Information provided by (Responsible Party): Johns Hopkins University

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: April 18, 2018
• Actual Primary Completion Date: June 17, 2020
• Actual Study Completion Date: July 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 60 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Maryland

Catholic Charities

Baltimore, Maryland, United States, 21201

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)

Documents provided by Johns Hopkins University:

Study Protocol  [PDF] July 9, 2021

Statistical Analysis Plan  [PDF] August 13, 2021

More Information

Additional Information:

Description of HHIE - S measure 

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03442296
• Other Study ID Numbers: IRB00144968; R33DC015062-03 ( U.S. NIH Grant/Contract )
• First Posted: February 22, 2018
• Results First Posted: October 14, 2021
• Last Update Posted: October 14, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• 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; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases