Evaluating Hearing Aid Service Delivery Models
Primary Purpose
Presbycusis, Aging, Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hearing aid
Sponsored by
About this trial
This is an interventional treatment trial for Presbycusis focused on measuring presbycusis, hearing aids
Eligibility 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
Sites / Locations
- IU Department of Speech & Hearing Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Audiologist-Based
Consumer Decides
Placebo
Arm Description
Audiologist selects hearing aid for patient
Consumer selects hearing aid
Patient fitted with hearing aid that is acoustically transparent.
Outcomes
Primary Outcome Measures
Profile of Hearing Aid Performance Benefit (PHAB)
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
Connected Speech Test (CST) Benefit
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.
Full Information
NCT ID
NCT01788423
First Posted
October 24, 2012
Last Updated
July 3, 2019
Sponsor
Indiana University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT01788423
Brief Title
Evaluating Hearing Aid Service Delivery Models
Official Title
Evaluating Hearing Aid Service Delivery Models
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbycusis, Aging, Hearing Loss
Keywords
presbycusis, hearing aids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Audiologist-Based
Arm Type
Experimental
Arm Description
Audiologist selects hearing aid for patient
Arm Title
Consumer Decides
Arm Type
Experimental
Arm Description
Consumer selects hearing aid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient fitted with hearing aid that is acoustically transparent.
Intervention Type
Device
Intervention Name(s)
hearing aid
Intervention Description
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Primary Outcome Measure Information:
Title
Profile of Hearing Aid Performance Benefit (PHAB)
Description
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).
Time Frame
two times: at hearing-aid fit and at 6-weeks post-fit
Secondary Outcome Measure Information:
Title
Connected Speech Test (CST) Benefit
Description
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.
Time Frame
two times: at hearing-aid fit and at 6-weeks post-fit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry E. Humes, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Department of Speech & Hearing Sciences
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405-7002
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Already available online with Open Access publication of the study in March, 2017.
IPD Sharing Access Criteria
Open Access to protocol, study forms, and detailed results via publication in March, 2017. De-identified data available from investigator upon request.
Citations:
PubMed Identifier
30938563
Citation
Humes LE, Kinney DL, Main AK, Rogers SE. A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Model. Am J Audiol. 2019 Mar 15;28(1):69-84. doi: 10.1044/2018_AJA-18-0082. Erratum In: Am J Audiol. 2019 Sep 13;28(3):730.
Results Reference
derived
PubMed Identifier
28252160
Citation
Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111. Erratum In: Am J Audiol. 2019 Sep 13;28(3):730.
Results Reference
derived
Learn more about this trial
Evaluating Hearing Aid Service Delivery Models
We'll reach out to this number within 24 hrs