Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions

NCT03442296 | Completed Results DMC

• 2 other identifiers: IRB00144968R33DC015062-03
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

Brief Summary

Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.

Conditions

Age-related Hearing Impairment 1; Personal Communication

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)

  Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.

  Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Secondary Outcomes (31)

• Change From Baseline in Revised UCLA Loneliness Scale

  Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

• Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)

  Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

• Change From Baseline in Short Form-12 (SF-12) Mental Component Score

  Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

• Change From Baseline in Short Form -12 (SF-12) Physical Component Score

  Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

• Change From Baseline in Cohen Social Network Index (SNI): Network Diversity

  Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

Immediate treatment with Baltimore HEARS intervention

Behavioral: Baltimore HEARS; Device: Baltimore HEARS

Delayed Treatment Group

PLACEBO COMPARATOR

3-month delayed treatment with Baltimore HEARS intervention

Behavioral: Baltimore HEARS; Device: Baltimore HEARS

Interventions

Baltimore HEARS BEHAVIORAL

Tailored aural rehabilitation for participant and communication partner (if applicable)

Delayed Treatment Group; Immediate Treatment Group

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older
• English-speaking
• Aural-oral verbal communication as primary communication modality
• Post-lingual hearing loss (Audiometric pure tone averages \[0.5-4kHz\] in both ears \>25 dB)
• Does not currently use a hearing amplification device or hearing aid
• Signed informed consent to participate in all study related activities
• Willing to regularly use listening device once provided for the remainder of their time in the study
• Hearing handicap as measured by HHIE-S score \>8
• Able to follow study instructions

You may not qualify if:

• Evidence of ear disease or pathology requiring further medical evaluation

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

Catholic Charities

Baltimore, Maryland, 21201, United States

Location

Weinberg Senior Living Communities

Baltimore, Maryland, 21215, United States

Location

Related Publications (7)

• Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.

  PMID: 6626295 BACKGROUND

• Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.

  PMID: 3718608 BACKGROUND

• 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. doi: 10.1097/00003446-199002000-00011.

  PMID: 2307305 BACKGROUND

• 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. doi: 10.1037//0022-3514.39.3.472.

  PMID: 7431205 BACKGROUND

• 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. doi: 10.1097/00005650-198807000-00007. No abstract available.

  PMID: 3393032 BACKGROUND

• Nieman CL, Betz J, Garcia Morales EE, Suen JJ, Trumbo J, Marrone N, Han HR, Szanton SL, Lin FR. Effect of a Community Health Worker-Delivered Personal Sound Amplification Device on Self-Perceived Communication Function in Older Adults With Hearing Loss: A Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2324-2333. doi: 10.1001/jama.2022.21820.

  PMID: 36538311 DERIVED

• Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.

  PMID: 35724253 DERIVED

Related Links

• Description of HHIE - S measure

MeSH Terms

Conditions

Age-Related Hearing Impairment 1; Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Carrie Nieman
• Organization: Johns Hopkins University School of Medicine

cnieman1@jhmi.edu

410-502-6965

Study Officials

• Frank R Lin, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Carrie L Nieman, MD, MPH

  Johns Hopkins University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 22, 2018
• Study Start: April 18, 2018
• Primary Completion: June 17, 2020
• Study Completion: July 14, 2021
• Last Updated: October 4, 2022
• Results First Posted: October 14, 2021

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)