The Baltimore HEARS Pilot Study

Johns Hopkins University

Status: Completed

Conditions: Age-related Hearing Impairment 1; Personal Communication

Treatments: Device: Baltimore HEARS

Study type: Interventional

Funder types: Other

Identifiers

NCT02045511

NA_00088278

Details and patient eligibility

About

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.

Full 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. The investigators 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.

Enrollment: 15 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups, including a placebo group

Immediate Treatment Group

Experimental group

Description:

Immediate treatment with Baltimore HEARS intervention

Treatment:

Device: Baltimore HEARS

Device: Baltimore HEARS

Delayed Treatment Group

Placebo Comparator group

Description:

3-month delayed treatment with Baltimore HEARS intervention

Treatment:

Device: Baltimore HEARS

Device: Baltimore HEARS