The Baltimore HEARS Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Johns Hopkins University
Sponsor:
Collaborator:
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Information provided by (Responsible Party):
Frank Lin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02045511
First received: January 22, 2014
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.


Condition Intervention
Age-related Hearing Impairment 1
Personal Communication
Behavioral: Baltimore HEARS
Device: Baltimore HEARS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change from baseline in Hearing Handicap Inventory for the Elderly (HHIE) at 1 month and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Treatment Group
Immediate treatment with Baltimore HEARS intervention
Behavioral: Baltimore HEARS
Tailored aural rehabilitation for participant and communication partner
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
Device: Baltimore HEARS
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Detailed Description:

Age-related hearing impairment is strongly associated with poorer communicative functioning and social isolation, but hearing impairment often goes undiagnosed and untreated, particularly among minority and low-income older adults. Novel interventions that translate research on social engagement, minority health, and hearing technology are needed to expand delivery of hearing health care to underserved older adults. The Baltimore Hearing Equality through Accessible Research and Solutions (HEARS) project will develop and pilot a first-in-kind community-based intervention to provide affordable, accessible, and effective hearing health care to minority and low-income older adults and their communication partners. The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components throughout the formative and evaluative processes. Participants and their communication partners will be randomized to an immediate treatment group or a 3-month delayed treatment group. We hypothesize that the intervention is associated with increased social engagement and communication, improved quality of life, and decreased loneliness and third-party disability in the immediate treatment compared to the delayed treatment group.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
  • Does not currently use a hearing amplification device or hearing aid
  • Signed informed consent to participate in baseline, 1 month, and 3 month assessments
  • Have a communication partner able to accompany them to all study-related appointments

Exclusion Criteria:

  • Individuals who do not fulfill inclusion criteria
  • Score ≤ 25 on the Montreal Cognitive Assessment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045511

Contacts
Contact: Frank Lin, MD, PhD 410-502-0150 flin1@jhmi.edu
Contact: Carrie L Nieman, MD, MPH 443-287-7779 cnieman1@jhmi.edu

Locations
United States, Maryland
Weinberg Senior Living Communities Recruiting
Baltimore, Maryland, United States, 21215
Principal Investigator: Frank Lin, MD, PhD         
Sub-Investigator: Carrie L Nieman, MD, MPH         
Sponsors and Collaborators
Johns Hopkins University
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Investigators
Principal Investigator: Frank Lin, MD, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Frank Lin, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02045511     History of Changes
Other Study ID Numbers: NA_00088278
Study First Received: January 22, 2014
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014