Assessment of e-Audiology for Providing Clinical Services and Support

Hearing Disability Clinical Trial

— eAudiology  

Official title:

Assessment of e-Audiology for Providing Clinical Services and Support for Age-related Hearing Loss: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048460
• Other study ID #: Pro00041124
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: April 15, 2020

Study information

• Verified date: February 2021
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hearing loss is a chronic disability and a major public health concern. As the U.S. population ages, hearing loss prevalence rates are expected to nearly double by 2060 (Goman, Reed et al. 2017). Given this projection and the negative, costly impacts of untreated hearing loss on health outcomes, there is a national emphasis on increasing access and affordability of hearing healthcare (HHC) (President's Council of Advisors on Science and Technology 2015, National Academies of Sciences 2016). Two significant factors hinder the achievement of successful HHC outcomes: First, US adults face structural barriers to accessing HHC including high cost, and limited, inflexible points of entry into the system (National Academies of Sciences 2016). Second, hearing aids are often the sole intervention offered. While hearing aids improve speech understanding in quiet, difficulties understanding speech in challenging listening environments remain. Many of these difficulties can be addressed by including hearing assistive technology [HAT] options in the intervention plan. Unfortunately, hearing aid uptake is low for adults with hearing loss, and HAT usage is reported among only a fraction of those who use hearing aids (Southall, Gagné et al. 2009, Hartley, Rochtchina et al. 2010, Chien and Lin 2012, Bainbridge and Ramachandran 2014). Technological advances in hearing aids and telecommunications, including the widespread availability of "e-Audiology" applications, have the potential to expand both access and affordability of HHC by allowing for greater flexibility, lower costs, and personalized intervention plans that take into account the listening and lifestyle needs of the individual. There is a lack of evidence, however, as to how e-Audiology and patient acceptance for e-Audiology impact HHC outcomes. There is an urgent need to understand the efficacy of accessible, patient-centered, and comprehensive HHC alternative delivery models, like e-Audiology, without which the critical public health problem of untreated hearing loss in adults will likely worsen.

With the long-term goal of enhancing decision-making by patients and providers and improving outcomes, the pilot data collected in this proposal will be used for an upcoming R01 submission which will be responsive to the NIDCD's call for research comparing different HHC delivery models and the utilization of new technologies to improve care. The overall objectives of this work are twofold. First, we will evaluate outcomes from an e-Audiology service delivery model. Second, we will determine the impact of patient preferences for delivery model on outcomes. The rationale of the proposed study is that the results will enhance the evidence-base for the use of e-Audiology as a mechanism for increasing HHC access for diverse adult populations. Results obtained will be submitted as pilot data in an upcoming R01 grant application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 89 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Deafness
• Hearing Disability
• Hearing Loss
• Hearing Loss, Age-Related
• Presbycusis
• Presbycusis, Bilateral

Intervention

Device:
• Delivery of hearing healthcare through eAudiology application
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.

Locations

Country	Name	City	State
United States	Auditory Rehabilitation and Clinical Trials Laboratory at the University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline on the Quick Speech-in-Noise (QuickSIN) Test	Participants repeat sentences presented at six signal-to-noise ratios (SNRs) and the 'SNR loss' is computed. The SNR loss is the dB SNR relative to the SNR required for normal hearing individuals to repeat back 50% of the key words correctly.; Higher scores on the signal to noise ratio loss scale indicates more difficulty with hearing speech-in-noise compared to normal hearing peers. The range of performance is from 2-dB SNR to 24-dB SNR. Scores are reported as the average SNR loss across all participants. The change in SNR loss was calculated based on the change in average score from baseline to 6-weeks post-intervention.	6 weeks post-intervention
Secondary	Change From Baseline on the Telehealth Acceptance Questionnaire (TAQ)	Telehealth Acceptance Questionnaire (TAQ; Wade, 2012). The TAQ is based on the Technology Acceptance Model, and will be used to assess participants' attitudes about telehealth as well as their beliefs regarding self-efficacy for telehealth use. The TAQ uses a visual analog scale and the units range from 0 mm (lowest acceptance of telehealth) to 100 mm (higher acceptance of telehealth). The scores are reported as an average across all participants. Change from baseline was calculated based on the change in average score from baseline to 6-weeks post-intervention.	6 weeks post-intervention
Secondary	International Outcome Inventory for Hearing Aids (IOI-HA)	The IOI-HA will be used to determine specific hearing aid benefits perceived by the participants following a sustained period of use. This a post-intervention measurement only as questions are specific to the intervention adopted.; The International Outcome Inventory scale ranges from 7 to 35. A higher score would indicate more perceived benefit from hearing aids.	6 weeks post-intervention