Community-Based Kiosks for Hearing Screening and Education

NCT ID: NCT01963104

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2048 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Automated hearing test

Subjects will take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up.

Group Type EXPERIMENTAL

Automated hearing test

Intervention Type PROCEDURE

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.

Pure-tone Screener test

Subjects will take a pure-tone hearing screening test and then receive recommendations for hearing healthcare follow-up.

Group Type EXPERIMENTAL

Pure-tone Screener test

Intervention Type PROCEDURE

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.

Digits-in-noise test

Subjects will take a digits-in-noise test and then receive recommendations for hearing healthcare follow-up.

Group Type EXPERIMENTAL

Digits-in-noise test

Intervention Type PROCEDURE

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.

No screening test

This group of subjects will not receive a screening test.

Group Type EXPERIMENTAL

No screening test

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Automated hearing test/Motivation video

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Pure-tone Screener/Motivation video

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Digits-in-noise test/Motivational video

Intervention Type PROCEDURE

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.

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

Group Type EXPERIMENTAL

No screening test/Motivational video

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Home Hearing Screening Test

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Home Hearing Screening Test/Brief video

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Portland VA Medical Center

FED

Sponsor Role lead

Responsible Party

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M. Patrick Feeney

Director of NCRAR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin P Feeney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Portland VA Medical Center, National Center for Rehabilitative Auditory Research

Locations

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Bay Pines VAHCS

Bay Pines, Florida, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Portland VA Medical Center, National Center for Rehabilitative Auditory Research

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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4R33DC011769-02

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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