Overview

This trial is active, not recruiting.

Conditions age-related hearing impairment 1, personal communication
Treatments baltimore hears
Sponsor Johns Hopkins University
Collaborator American Academy of Otolaryngology-Head and Neck Surgery Foundation
Start date February 2014
End date September 2015
Trial size 100 participants
Trial identifier NCT02045511, NA_00088278

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Immediate treatment with Baltimore HEARS intervention
baltimore hears
Tailored aural rehabilitation for participant and communication partner
baltimore hears
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
(Placebo Comparator)
3-month delayed treatment with Baltimore HEARS intervention
baltimore hears
Tailored aural rehabilitation for participant and communication partner
baltimore hears
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Primary Outcomes

Measure
Change from baseline in Hearing Handicap Inventory for the Elderly (HHIE) at 1 month and 3 months
time frame: 3 months

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions
Principal investigator Frank Lin, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.