Clinical trial NCT02045511: The Baltimore HEARS Pilot Study
Official title: The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Hearing Impairment 1
Personal Communication
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngology-Head and Neck Surgery Foundation
First posted: 2014-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Change From Baseline in Revised QDS at 3 Months
timeFrame: 3 months
measure: Change From Baseline in Revised UCLA at 3 Months
timeFrame: 3 months
measure: Change From Baseline in PHQ-9 at 3 Months
timeFrame: 3 months
measure: Change From Baseline in SF-36 Mental Component at 3 Months
timeFrame: 3 months
measure: Change From Baseline in SF-36 Physical Component at 3 Months
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Weinberg Senior Living Communities
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Frank Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
citation: Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
citation: 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.
citation: 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.
citation: 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.