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Clinical Trials/NCT02045511
NCT02045511
Completed
Not Applicable

The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions

Johns Hopkins University1 site in 1 country15 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Age-related Hearing Impairment 1
Sponsor
Johns Hopkins University
Enrollment
15
Locations
1
Primary Endpoint
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

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. 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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
September 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months

Time Frame: 3 months

Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure Description: Measure was collected through a one-on-one interview with a trained data collector. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap

Secondary Outcomes

  • Change From Baseline in Revised QDS at 3 Months(3 months)
  • Change From Baseline in Revised UCLA at 3 Months(3 months)
  • Change From Baseline in SF-36 Mental Component at 3 Months(3 months)
  • Change From Baseline in PHQ-9 at 3 Months(3 months)
  • Change From Baseline in SF-36 Physical Component at 3 Months(3 months)

Study Sites (1)

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