The Baltimore HEARS Pilot Study

Not Applicable

Completed

Conditions: Age-related Hearing Impairment 1
Personal Communication

Interventions: Device: Baltimore HEARS

Registration Number: NCT02045511

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Treatment Group	Baltimore HEARS	Immediate treatment with Baltimore HEARS intervention
Delayed Treatment Group	Baltimore HEARS	3-month delayed treatment with Baltimore HEARS intervention

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months	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 Outcome Measures

Name	Time	Method
Change From Baseline in Revised QDS at 3 Months	3 months	Mean change, Unpooled - comparing baseline to 3 month follow-up visit \[1\] Measure Description: Measure was collected through a one-on-one interview conducted by a trained data collector. Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5) Scoring is from 1 (worst) to 5 (best). Scores were summed across each of the 5 survey questions resulting in a total range of 5 (worst) to 25 (best) Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference.
Change From Baseline in Revised UCLA at 3 Months	3 months	Mean change, Unpooled - comparing baseline to 3 month follow-up visit \[1\] Measure Description: Measure was collected via a one-on-one interview conducted by a trained data collector. 20-item Likert-type scale. Total score is sum of the 20 items, scores range from 20 to 80. Lower values equate to lower levels of loneliness and higher values equate to higher levels of loneliness. Perry et al., 1990 uses the following score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness
Change From Baseline in SF-36 Mental Component at 3 Months	3 months	Mean change, Unpooled - comparing baseline to 3 month follow-up visit Data were collected via one-on-one interviews with trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = \[2-74\].
Change From Baseline in PHQ-9 at 3 Months	3 months	Mean change, Unpooled - comparing baseline to 3 month follow-up visit \[1\] Measure Description: Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline to 3 months was reported. An increase in the score from baseline to three months (a positive number) indicates a worsening in depression severity. A decrease in the score from baseline to three months (a negative number) indicates a reduction in depression severity.
Change From Baseline in SF-36 Physical Component at 3 Months	3 months	Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure collected via one-on-one interview conducted by trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = \[4-71\].