- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048460
Assessment of e-Audiology for Providing Clinical Services and Support (eAudiology)
Assessment of e-Audiology for Providing Clinical Services and Support for Age-related Hearing Loss: A Pilot Study
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33620
- Auditory Rehabilitation and Clinical Trials Laboratory at the University of South Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: eAudiology
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline on the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S)
Time Frame: 6 weeks post-intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline on the Quick Speech-in-Noise (QuickSIN) Test
Time Frame: 6 weeks post-intervention
|
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
|
Change From Baseline on the Telehealth Acceptance Questionnaire (TAQ)
Time Frame: 6 weeks post-intervention
|
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
|
International Outcome Inventory for Hearing Aids (IOI-HA)
Time Frame: 6 weeks post-intervention
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00041124
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hearing Disability
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenActive, not recruitingHearing DisabilityBelgium
-
Universitaire Ziekenhuizen KU LeuvenActive, not recruitingHearing DisabilityBelgium
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenEnrolling by invitation
-
University of ArkansasCompleted
-
University of North Carolina, Chapel HillMed-El CorporationWithdrawnHearing Loss | Hearing DisabilityUnited States
-
Oticon MedicalRecruitingEar Diseases | Hearing Loss, Conductive | Hearing Loss Mixed | Hearing Disability | Conductive Hearing Loss | Conductive Hearing Loss, Bilateral | Conductive Hearing Loss, UnilateralUnited Kingdom
-
University of British ColumbiaEnrolling by invitationHearing Loss | Motivation | Hearing Disability | Hearing Disorders and DeafnessCanada
-
University of ExtremaduraUniversity of CadizCompletedDisability Physical | Disabilities Multiple | Disability, Intellectual | Disability Hearing | Disability, VisionSpain
-
Ottawa Hospital Research InstituteAdvanced BionicsUnknownHearing Disability | Cochlear Implant | Hearing Disorders and DeafnessCanada
-
Region SkaneHorselvarden Region OstergotlandEnrolling by invitationOtorhinolaryngologic Diseases | Ear Diseases | Sensation Disorders | Hearing Loss | Hearing Disorders | Hearing Impairment | Hearing DisabilitySweden
Clinical Trials on Delivery of hearing healthcare through eAudiology application
-
Johns Hopkins UniversityUniversity of South Florida; University of Minnesota; National Institute on Deafness... and other collaboratorsActive, not recruiting
-
Catholic University of the Sacred HeartCompleted
-
Macfarlane Burnet Institute for Medical Research...National Health and Medical Research Council, Australia; Gilead Sciences; The... and other collaboratorsRecruitingHepatitis C | Hepatitis C, Chronic | Chronic Hepatitis cAustralia
-
Beyond Air Inc.WithdrawnCOVID-19 | Pneumonia, Viral | SARS-CoV 2 | Corona Virus Infection | Respiratory Disease
-
Antalya Training and Research HospitalRecruiting
-
University of Texas at AustinHarris HealthEnrolling by invitation
-
Hospital de Clinicas de Porto AlegreCompletedDiabetes Mellitus, Type 2Brazil
-
Hellenic Society of Obstetrics and GynecologyNational and Kapodistrian University of Athens; St George's, University of... and other collaboratorsCompleted