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Patient-Centered Hearing Aid Trial (P-CHAT)

Primary Purpose

Hearing Aids, Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing Aids
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Aids

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 50 - 79 years old.
  • Mild or moderate hearing difficulty.
  • Normal cognition.
  • No prior hearing aid experience.
  • Ability and willingness to pay privately ($650.00) for hearing aids
  • Ability to read and understand English
  • Symmetric hearing loss, no greater than moderate in degree

Exclusion Criteria:

-

Sites / Locations

  • Northwestern Memorial HospitalRecruiting
  • Northwestern University Center for Audiology, Speech, Language, and LearningRecruiting
  • Sertoma Speech and Hearing CenterRecruiting
  • University of Texas Medical BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Audiology-Based Best Practice

Consumer Decides

Efficient Fitting

Arm Description

Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.

Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.

Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.

Outcomes

Primary Outcome Measures

Profile of Hearing Aid Benefit
66-item self-assessment, disability-based inventory.

Secondary Outcome Measures

Hearing Handicap Inventory for the Elderly
A self-administered scale to identify problems related to hearing loss.

Full Information

First Posted
October 31, 2020
Last Updated
January 10, 2023
Sponsor
Northwestern University
Collaborators
Leslie Rolph, Tom Wardzala, Malini Patel, Tracy Winn, Larry E. Humes, Mary Meskan
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1. Study Identification

Unique Protocol Identification Number
NCT04618315
Brief Title
Patient-Centered Hearing Aid Trial
Acronym
P-CHAT
Official Title
Comparison of Direct to Consumer Delivery Models for Hearing Devices
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Leslie Rolph, Tom Wardzala, Malini Patel, Tracy Winn, Larry E. Humes, Mary Meskan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.
Detailed Description
Hearing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in ~40% of those over the age of 60 years. Only 20% of these individuals purchase and use hearing aids. The Over-the-Counter Hearing Aid Act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. While this legislation directs the Food and Drug Administration (FDA) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. Patients do not have the evidence they need to decide between modes of acquiring hearing aids. The current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. Two methods of patient-driven methods of selecting and fitting hearing aids will be compared against audiology-based best practice fitting. Individuals who perceive mild or moderate hearing difficulty will be randomly assigned to one of three fitting arms. Satisfaction and benefit from hearing aids will be assessed at six weeks and six months after initial fit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Aids, Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three arm blinded randomized control trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
The principle investigators and the audiologists conducting the outcome measures will be blinded to group assignment.
Allocation
Randomized
Enrollment
591 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Audiology-Based Best Practice
Arm Type
Active Comparator
Arm Description
Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Arm Title
Consumer Decides
Arm Type
Experimental
Arm Description
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Arm Title
Efficient Fitting
Arm Type
Experimental
Arm Description
Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Intervention Type
Device
Intervention Name(s)
Hearing Aids
Intervention Description
Receiver-in-the-ear hearing aids.
Primary Outcome Measure Information:
Title
Profile of Hearing Aid Benefit
Description
66-item self-assessment, disability-based inventory.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hearing Handicap Inventory for the Elderly
Description
A self-administered scale to identify problems related to hearing loss.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Duration of hearing aid use
Description
Average hours of hearing aid use per day.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 - 79 years old. Mild or moderate hearing difficulty. Normal cognition. No prior hearing aid experience. Ability and willingness to pay privately ($650.00) for hearing aids Ability to read and understand English Symmetric hearing loss, no greater than moderate in degree Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sumit Dhar, PhD
Phone
847 491 2470
Email
s-dhar@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Meskan, PhD
Phone
847 467 0123
Email
Mary.meskan@northwestern.edu
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malini Patel, AuD
Email
mpatel@nm.org
Facility Name
Northwestern University Center for Audiology, Speech, Language, and Learning
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Winn, AuD
Phone
847-491-3165
Email
tracy.winn@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Diane Novak, AuD
Phone
847 491 3165
Email
d-novak@northwestern.edu
Facility Name
Sertoma Speech and Hearing Center
City
Palos Hills
State/Province
Illinois
ZIP/Postal Code
60465
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Wardzala, AuD
Email
twardzala@sertomacenter.org
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Rolph, AuD
Email
lkrolph@utmb.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Patient-Centered Hearing Aid Trial

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