Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions
NCT ID: NCT03442296
Last Updated: 2022-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
151 participants
INTERVENTIONAL
2018-04-18
2021-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Immediate Treatment Group
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.
Delayed Treatment Group
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Evidence of ear disease or pathology requiring further medical evaluation
60 Years
100 Years
ALL
Yes
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Frank R Lin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Carrie L Nieman, MD, MPH
Role: STUDY_DIRECTOR
Johns Hopkins University
Locations
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Catholic Charities
Baltimore, Maryland, United States
Weinberg Senior Living Communities
Baltimore, Maryland, United States
Countries
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References
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Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011.
Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
Nieman CL, Betz J, Garcia Morales EE, Suen JJ, Trumbo J, Marrone N, Han HR, Szanton SL, Lin FR. Effect of a Community Health Worker-Delivered Personal Sound Amplification Device on Self-Perceived Communication Function in Older Adults With Hearing Loss: A Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2324-2333. doi: 10.1001/jama.2022.21820.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Description of HHIE - S measure
Other Identifiers
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IRB00144968
Identifier Type: -
Identifier Source: org_study_id
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