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Evaluating Hearing Aid Service Delivery Models

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ClinicalTrials.gov Identifier: NCT01788423
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Larry Humes, Indiana University

Brief Summary:
The purpose of this study is to compare the outcomes for two different hearing-aid delivery models. In one model, the audiologist selects and fits the hearing aid and, in the other model, the consumer does this directly.

Condition or disease Intervention/treatment Phase
Presbycusis Aging Hearing Loss Device: hearing aid Not Applicable

Detailed Description:

The objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (OTC) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models. The design of this study was a single-site, prospective, double-blind placebo-controlled randomized trial with three parallel branches: (a) audiology best practices (AB), (b) consumer decides OTC model (CD), and (c) placebo devices (P). Outcome measures were obtained after a typical 6-week trial period with follow-up 4-week AB-based trial for those initially assigned to CD and P groups.

Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic. Participants were adults, ages 55-79 years,with mild-to-moderate hearing loss. Intervention(s): All participants received the same highenddigital mini-behind-the-ear hearing aids fitted bilaterally.AB and P groups received best-practice services from audiologists; differing mainly in use of appropriate (AB) or placebo (P) hearing aid settings. CD participants self-selected their own pre-programmed hearing aids via an OTC model. Primary outcome measure was a 66-item self-report, Profile of Hearing Aid Performance/Benefit. Secondary outcome measure was the Connected Speech Test benefit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Hearing Aid Service Delivery Models
Study Start Date : November 2012
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
Experimental: Audiologist-Based
Audiologist selects hearing aid for patient
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

Experimental: Consumer Decides
Consumer selects hearing aid
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

Placebo Comparator: Placebo
Patient fitted with hearing aid that is acoustically transparent.
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.




Primary Outcome Measures :
  1. Profile of Hearing Aid Performance Benefit (PHAB) [ Time Frame: two times: at hearing-aid fit and at 6-weeks post-fit ]

    Change from unaided to aided performance on the Profile of Hearing Aid Performance with the difference in aided and unaided scores labeled Profile of Hearing Aid Benefit (PHAB), a self-report measure of benefit. The aided and unaided PHAP scores are proportions of time difficulties encountered in various listening situations. Low PHAP scores indicate less frequent difficulties. When subtracting aided from unaided PHAP scores, a positive PHAB score reflects less frequent problems when wearing a hearing aid compared to without. The range of possible PHAB scores are -1.0 to +1.0 with 0.0 indicating no difference between aided and unaided performance.

    There are seven subscales of the PHAP/PHAB and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHABglobal. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC).



Secondary Outcome Measures :
  1. Connected Speech Test (CST) Benefit [ Time Frame: two times: at hearing-aid fit and at 6-weeks post-fit ]
    A standardized speech-perception test, based on meaningful sentences and keyword scoring, the Connected Speech Test (CST) was administered unaided and aided. Each CST score represents the percentage of keywords (out of 50) repeated correctly following presentation via loudspeakers. Scores can range from 0 to 100% correct with higher scores indicating better speech perception. For the CST benefit scores reported below, unaided CST scores are subtracted from aided scores such that positive values represent better performance for aided than unaided listening. The possible range of CST benefit scores is -100 to +100 with 0 representing no difference between unaided and aided speech-perception performance.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (for groups 1-4)

  • 55-79 yrs of age
  • Native English speaker
  • no prior hearing aid use
  • ability to read 18 point font

Exclusion Criteria: (for groups 1-3)

  • hearing loss too severe or too mild for hearing aid
  • middle-ear conductive pathology present
  • asymmetrical hearing loss
  • presence of dementia, Parkinson's disease, or other neurological disorder

Exclusion Criteria : (for groups 1-4)

- subject not interested in purchasing hearing aids


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788423


Locations
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United States, Indiana
IU Department of Speech & Hearing Sciences
Bloomington, Indiana, United States, 47405-7002
Sponsors and Collaborators
Indiana University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Larry E. Humes, PhD Indiana University
  Study Documents (Full-Text)

Documents provided by Larry Humes, Indiana University:
Study Protocol  [PDF] November 2, 2012
No Statistical Analysis Plan (SAP) exists for this study.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Larry Humes, Distinguished Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01788423    
Other Study ID Numbers: 1111007504
R01DC011771 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2013    Key Record Dates
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol, study forms, and final publication all available via Open Access publication in the American Journal of Audiology in March, 2017. De-identified individual data available from PI upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Already available online with Open Access publication of the study in March, 2017.
Access Criteria: Open Access to protocol, study forms, and detailed results via publication in March, 2017. De-identified data available from investigator upon request.
Keywords provided by Larry Humes, Indiana University:
presbycusis
hearing aids
Additional relevant MeSH terms:
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Hearing Loss
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural