Baltimore HEARS: Hearing Equality Through Accessible Research & Solutions (HEARS)

• 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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 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
Estimated Primary Completion Date :	December 31, 2019
Estimated Study Completion Date :	July 31, 2020

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. 10 Item Hearing Handicap Inventory for the Elderly Screening (HHIE-S) [ Time Frame: Change between Baseline and 3 months post-intervention ]
   Self reported social and emotional effect of hearing loss. Each item has three answers: "Yes", "Sometimes" and "No", with "Yes" scoring 4, "Sometimes" scoring 2, and "No" scoring 0. An individual can score up to a maximum of 40 points (maximum handicap). A score of 0-8 indicates no handicap, 10-24 is moderate handicap, and 26 or greater signifies severe hearing handicap.

Secondary Outcome Measures :

1. Changes in Self-reported Loneliness [ Time Frame: Change between Baseline and 3 months post-intervention ]
   Self reported loneliness through the University of California, Los Angeles (UCLA) Loneliness Scale, a 20 item scale to measure loneliness and social isolation. Participants answer questions with "I often feel this way" (4) , "I sometimes feel this way" (3), " I rarely feel this way" (2), or "I never feel this way" (1). The maximum score is 80.
2. Change in Self-reported Depression [ Time Frame: Change between Baseline and 3 months post-intervention ]
   Self-reported depression through the Patient Health Questionnaire (PHQ-9) Patient Depression Questionnaire. The individual recalls how often, over the last two weeks, they have been bothered by problems: "not at all" (0), "several days" (1), "more than half the days" (2), or "nearly every day" (3) . The maximum score is 27. A score of 0-9 indicates none to mild depression and higher scores indicating more severe depression.

Eligibility Criteria

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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

Contacts

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Contact: Frank R Lin, MD, PhD	410-502-0150	flin1@jhmi.edu
Contact: Jami Cheng	4109550920	jcheng33@jhmi.edu

Locations

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United States, Maryland
Catholic Charities	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Arnold Eppel aeppel@cc-md.org
Principal Investigator: Frank Lin, MD, PhD
Sub-Investigator: Carrie Nieman, MD, MPH
Sub-Investigator: Jonathan Suen, AuD
Weinberg Senior Living Communities	Recruiting
Baltimore, Maryland, United States, 21215
Contact: Tiffany Nicholette tnicolette@emcmgmt.com
Principal Investigator: Frank Lin, MD, PhD
Sub-Investigator: Carrie L Nieman, MD, MPH
Sub-Investigator: Jonathan Suen, AuD

Sponsors and Collaborators

Johns Hopkins University

National Institute on Deafness and Other Communication Disorders (NIDCD)

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.

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Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT03442296 History of Changes
Other Study ID Numbers:	IRB00144968; R33DC015062-03 ( U.S. NIH Grant/Contract )
First Posted:	February 22, 2018
Last Update Posted:	March 8, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Hearing Loss; Deafness; Presbycusis; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases	Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Hearing Loss, Sensorineural