The Baltimore HEARS Pilot Study

NCT ID: NCT02045511

Last Updated: 2018-08-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Age-related Hearing Impairment 1 Personal Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Immediate Treatment Group

Immediate treatment with Baltimore HEARS intervention

Group Type EXPERIMENTAL

Baltimore HEARS

Intervention Type BEHAVIORAL

Tailored aural rehabilitation for participant and communication partner

Baltimore HEARS

Intervention Type DEVICE

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Delayed Treatment Group

3-month delayed treatment with Baltimore HEARS intervention

Group Type PLACEBO_COMPARATOR

Baltimore HEARS

Intervention Type BEHAVIORAL

Tailored aural rehabilitation for participant and communication partner

Baltimore HEARS

Intervention Type DEVICE

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Interventions

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Baltimore HEARS

Tailored aural rehabilitation for participant and communication partner

Intervention Type BEHAVIORAL

Baltimore HEARS

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Intervention Type DEVICE

Eligibility Criteria

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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

* Score ≤ 25 on the Montreal Cognitive Assessment
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Academy of Otolaryngology-Head and Neck Surgery Foundation

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Weinberg Senior Living Communities

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 6626295 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3718608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2307305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7431205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3393032 (View on PubMed)

Related Links

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Other Identifiers

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NA_00088278

Identifier Type: -

Identifier Source: org_study_id

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