The Baltimore HEARS Pilot Study (HEARS)

• ClinicalTrials.gov Identifier: NCT02045511
• Recruitment Status: Completed
• First Posted: January 27, 2014
• Results First Posted: September 6, 2017
• Last Update Posted: August 22, 2018
• Sponsor: Johns Hopkins University
• Collaborator: American Academy of Otolaryngology-Head and Neck Surgery Foundation
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Age-related Hearing Impairment 1; Personal Communication	Behavioral: Baltimore HEARS; Device: Baltimore HEARS	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• 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
• Study Start Date: February 2014
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

2. 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

3. 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.

4. 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].

5. 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].

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• 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

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:

Description of HHIE - S measure 

Publications:

Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42.

Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5.

Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61.

Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80.

Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02045511
• Other Study ID Numbers: NA_00088278
• First Posted: January 27, 2014
• Results First Posted: September 6, 2017
• Last Update Posted: August 22, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Hearing Loss; Deafness; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases