Community-Based Kiosks for Hearing Screening and Education

November 22, 2019 updated by: M. Patrick Feeney, Portland VA Medical Center
The overall goal of the project is to evaluate innovative, cost-effective, community-based automated hearing screening and education methods to motivate individuals with mild-to-moderate hearing loss to enter the hearing healthcare system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2048

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bay Pines, Florida, United States, 33844
        • Bay Pines VAHCS
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center, National Center for Rehabilitative Auditory Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: :

  • Some subjects will have a complaint of hearing difficulty without a recent hearing evaluation

Exclusion Criteria:

  • For all groups: minimum age 18 years. No current hearing aid use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automated hearing test
Subjects will take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up.
Procedure: Automated hearing test
Subjects will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: Pure-tone Screener test
Subjects will take a pure-tone hearing screening test and then receive recommendations for hearing healthcare follow-up.
Procedure: Pure-tone Screener test
During the test different tones are going to be presented at one volume level. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: Digits-in-noise test
Subjects will take a digits-in-noise test and then receive recommendations for hearing healthcare follow-up.
Procedure: Digits-in-noise test
During the test subjects will hear a pattern of 3 numbers with variable noise in the background and identify the pattern they hear, and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: No screening test
This group of subjects will not receive a screening test.
Procedure: No screening test
This group of subjects will not receive a screening test. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: Automated hearing test/Motivation video
Subjects will take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up. They will then watch a brief video that shows how hearing works and learn about the different types of hearing loss.
Procedure: Automated hearing test/Motivation video
Subjects will take an automated hearing test that presents tones at different pitches and volumes.Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: Pure-tone Screener/Motivation video
Subjects will take a pure-tone hearing screening test and then receive recommendations for hearing healthcare follow- up. They will then watch a brief video that shows how hearing works and learn about the different types of hearing loss.
Procedure: Pure-tone Screener/Motivation video
During the test different tones are going to be presented at one volume level. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: Digits-in-noise test/Motivational video
Subjects will take a digits-in-noise test and then receive recommendations for hearing healthcare follow-up.They will then watch a brief video that shows how hearing works and learn about the different types of hearing loss.
Procedure: Digits-in-noise test/Motivational video
During the test subjects will hear a pattern of 3 numbers with variable noise in the background and identify the pattern they hear, and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: No screening test/Motivational video
This group of subjects will not receive a screening test. They will watch a brief video that shows how hearing works and learn about the different types of hearing loss
Procedure: No screening test/Motivational video
This group of subjects will not receive a screening test. They will watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: Home Hearing Screening Test
Subjects will be taught the set-up for a home hearing screening test, take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up.
Procedure: Home Hearing Screening Test
Subjects will be taught the set-up for a home hearing screening test and will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
Experimental: Home Hearing Screening Test/Brief video

Subjects will be taught the set-up for a home hearing screening test, take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up.

They will then watch a brief video that shows how hearing works and learn about the different types of hearing loss.
Procedure: Home Hearing Screening Test/Brief video

Subjects will be taught the set-up for a home hearing screening test and will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss.

Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Record number of participants who sought hearing healthcare 6 months after the initial visit.
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Record number of participants whose attitude about hearing health care has changed 6 months after the initial visit.
Time Frame: 4 years
4 years

Other Outcome Measures

Outcome Measure
Time Frame
Record which hearing screening method was best at motivating subjects to pursue hearing healthcare.
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portland VA Medical Center

Investigators

  • Principal Investigator: Martin P Feeney, Ph.D., Portland VA Medical Center, National Center for Rehabilitative Auditory Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4R33DC011769-02 (U.S. NIH Grant/Contract)

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.

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