Assessment of e-Audiology for Providing Clinical Services and Support

NCT04048460 | Completed Results

• 1 other identifier: Pro00041124
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Technological advances in hearing aids and telecommunications, including the widespread availability of telehealth (referred to in this proposal as "e-Audiology") applications, have the potential to expand both access and affordability of hearing aids for those with age-related hearing loss (ARHL). E-Audiology is used by clinicians in a variety of settings, including private practice, university clinics, and the Veterans Administration. The American Speech-Language-Hearing Association recently updated the Scope of Practice guidelines for audiology to include telehealth as "an alternative method of service delivery that en-compasses both diagnostics and intervention services.", including all aspects of hearing aid selection, fitting, and follow-up counseling and rehabilitation. However, given the paucity of evidence of comparative efficacy between office-based service delivery and e-Audiology in real-world settings, patients and relevant stakeholders are faced with a major decisional dilemma when determining which mode of service delivery would be optimal for addressing the needs, preferences, and lifestyles of those with ARHL. Thus, the purpose of this study is to determine the benefits, drawbacks, and patient satisfaction associated with e-Audiology delivery of hearing aid fitting, services, and supports for older adults with mild to moderate ARHL. We plan to use data collected in this pilot study for a future R01 submission to the NIH.

Conditions

Hearing Loss, Age-Related; Presbycusis, Bilateral; Hearing Disability

Keywords

telehealth; eAudiology; accessibility; Age-related hearing loss

Outcome Measures

Primary Outcomes (1)

• Change From Baseline on the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S)

  The Hearing Handicap Inventory for the Elderly Screening (HHIE-S) (Ventry and Weinstein 1982, Newman and Weinstein 1988) will be used to measure self-reported hearing difficulties. The Hearing Handicap Inventory scale is reported as an average across all participants and has a minimum value of 0 and a maximum value of 40. Higher scores indicate more perceived social and emotional difficulty due to an individuals hearing loss. Change in HHIE scores were calculated based on the change from baseline to 6 weeks-post intervention.

  6 weeks post-intervention

Secondary Outcomes (3)

• Change From Baseline on the Quick Speech-in-Noise (QuickSIN) Test

  6 weeks post-intervention

• Change From Baseline on the Telehealth Acceptance Questionnaire (TAQ)

  6 weeks post-intervention

• International Outcome Inventory for Hearing Aids (IOI-HA)

  6 weeks post-intervention

Study Arms (1)

eAudiology

EXPERIMENTAL

Participants will receive bilateral, behind-the-ear hearing aids as part of this study. The intervention will involve e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions will consist of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions will take place over the course of approximately 6 weeks.

Device: Delivery of hearing healthcare through eAudiology application

Interventions

Delivery of hearing healthcare through eAudiology application DEVICE

Participants will receive bilateral, behind-the-ear hearing aids as part of this study. The intervention will involve e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions will consist of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions will take place over the course of approximately 6 weeks.

eAudiology

Eligibility Criteria

• Age: 70 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 70 years or older
• Community-dwelling
• Can speak and read English fluently, assessed by self-report
• Mild to severe sloping hearing loss, as determined by a 4-frequency pure-tone average (0.5 to 4.0 kHz) of \> 30 dB HL in the better ear and no greater than 90 dB at any frequency
• Cognitively intact, as determined by a Mini Mental State Exam (MMSE) score of 23 or greater
• Regular access to computer, tablet, or "smart device" capable of delivering the e-Audiology platform

You may not qualify if:

• Bilateral conductive hearing loss, defined as a \> 10 dB air-bone gap at 2 or more frequencies
• Corrected vision no worse than 20/63, assessed by the MN Read Acuity vision screening
• Unwillingness to use hearing aids on a daily basis, determined by self-report

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Auditory Rehabilitation and Clinical Trials Laboratory at the University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Conditions

Presbycusis

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michelle Arnold, AuD, PhD, CCC-A Assistant Professor
• Organization: University of South Florida Department of Communication Sciences & Disorders

mlarnold@usf.edu

(813) 974-1262

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: August 15, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02

Locations

US (1)