Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03442296
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Johns Hopkins University

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

Layout table for study information
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
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442296


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Frank R Lin, MD, PhD Johns Hopkins University
Additional Information:
Publications:
Layout table for additonal information
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    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms