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The Baltimore HEARS Pilot Study (HEARS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02045511
First Posted: January 27, 2014
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Information provided by (Responsible Party):
Johns Hopkins University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)-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 Outcome Measures:
  • Change From Baseline in Revised QDS at 3 Months [ Time Frame: 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 [ Time Frame: 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 PHQ-9 at 3 Months [ Time Frame: 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 Mental Component at 3 Months [ Time Frame: 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 SF-36 Physical Component at 3 Months [ Time Frame: 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].



Enrollment: 15
Study Start Date: February 2014
Study Completion Date: September 2015
Primary Completion Date: September 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. 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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045511


Locations
United States, Maryland
Weinberg Senior Living Communities
Baltimore, Maryland, United States, 21215
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

Additional Information:
Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02045511     History of Changes
Other Study ID Numbers: NA_00088278
First Submitted: January 22, 2014
First Posted: January 27, 2014
Results First Submitted: April 17, 2017
Results First Posted: September 6, 2017
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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