Trial Outcomes & Findings for Assessment of e-Audiology for Providing Clinical Services and Support (NCT NCT04048460)
NCT ID: NCT04048460
Last Updated: 2021-03-04
Results Overview
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.
COMPLETED
NA
10 participants
6 weeks post-intervention
2021-03-04
Participant Flow
Participant milestones
| Measure |
eAudiology
Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of e-Audiology for Providing Clinical Services and Support
Baseline characteristics by cohort
| Measure |
eAudiology
n=10 Participants
Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention will involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions will consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
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Age, Categorical
>=65 years
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10 Participants
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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9 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Unaided Quick Speech In Noise Test (QuickSIN)
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7.75 Decibels
STANDARD_DEVIATION 5.75 • n=5 Participants
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Hearing Handicap Inventory for the Elderly Screening (HHIE-S)
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9.5 Scores on a scale
STANDARD_DEVIATION 2.72 • n=5 Participants
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Telehealth Acceptance Questionnaire (TAQ)
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8.29 mm
STANDARD_DEVIATION 1.17 • n=5 Participants
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PRIMARY outcome
Timeframe: 6 weeks post-interventionThe 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.
Outcome measures
| Measure |
eAudiology
n=10 Participants
Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
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Change From Baseline on the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S)
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3.2 scores on a scale
Standard Deviation 3.68
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SECONDARY outcome
Timeframe: 6 weeks post-interventionParticipants 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.
Outcome measures
| Measure |
eAudiology
n=10 Participants
Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
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Change From Baseline on the Quick Speech-in-Noise (QuickSIN) Test
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5.0 Decibels
Standard Deviation 4.41
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SECONDARY outcome
Timeframe: 6 weeks post-interventionTelehealth 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.
Outcome measures
| Measure |
eAudiology
n=10 Participants
Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
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Change From Baseline on the Telehealth Acceptance Questionnaire (TAQ)
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8.79 mm
Standard Deviation 1.49
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SECONDARY outcome
Timeframe: 6 weeks post-interventionThe 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.
Outcome measures
| Measure |
eAudiology
n=10 Participants
Participants received bilateral, behind-the-ear hearing aids as part of this study. The intervention involved e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions consisted of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions took place over the course of approximately 6 weeks from baseline.
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International Outcome Inventory for Hearing Aids (IOI-HA)
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31.9 units on a scale
Standard Deviation 2.60
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Adverse Events
eAudiology
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michelle Arnold, AuD, PhD, CCC-A Assistant Professor
University of South Florida Department of Communication Sciences & Disorders
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place