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Community-Based Kiosks for Hearing Screening and Education

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated hearing test
Pure-tone Screener test
Digits-in-noise test
No screening test
Automated hearing test/Motivation video
Pure-tone Screener/Motivation video
Digits-in-noise test/Motivational video
No screening test/Motivational video
Home Hearing Screening Test
Home Hearing Screening Test/Brief video
Sponsored by
Portland VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hearing Loss focused on measuring hearing test, audiology, healthcare utilization,, patient education, hearing screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bay Pines VAHCS
  • University of Minnesota
  • Ohio State University
  • Portland VA Medical Center, National Center for Rehabilitative Auditory Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Automated hearing test

Pure-tone Screener test

Digits-in-noise test

No screening test

Automated hearing test/Motivation video

Pure-tone Screener/Motivation video

Digits-in-noise test/Motivational video

No screening test/Motivational video

Home Hearing Screening Test

Home Hearing Screening Test/Brief video

Arm Description

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

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

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

This group of subjects will not receive a screening test.

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.

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.

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.

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

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.

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.

Outcomes

Primary Outcome Measures

Record number of participants who sought hearing healthcare 6 months after the initial visit.

Secondary Outcome Measures

Record number of participants whose attitude about hearing health care has changed 6 months after the initial visit.

Full Information

First Posted
September 12, 2013
Last Updated
November 22, 2019
Sponsor
Portland VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01963104
Brief Title
Community-Based Kiosks for Hearing Screening and Education
Official Title
Community-Based Kiosks for Hearing Screening and Education
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
hearing test, audiology, healthcare utilization,, patient education, hearing screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2048 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automated hearing test
Arm Type
Experimental
Arm Description
Subjects will take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up.
Arm Title
Pure-tone Screener test
Arm Type
Experimental
Arm Description
Subjects will take a pure-tone hearing screening test and then receive recommendations for hearing healthcare follow-up.
Arm Title
Digits-in-noise test
Arm Type
Experimental
Arm Description
Subjects will take a digits-in-noise test and then receive recommendations for hearing healthcare follow-up.
Arm Title
No screening test
Arm Type
Experimental
Arm Description
This group of subjects will not receive a screening test.
Arm Title
Automated hearing test/Motivation video
Arm Type
Experimental
Arm Description
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.
Arm Title
Pure-tone Screener/Motivation video
Arm Type
Experimental
Arm Description
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.
Arm Title
Digits-in-noise test/Motivational video
Arm Type
Experimental
Arm Description
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.
Arm Title
No screening test/Motivational video
Arm Type
Experimental
Arm Description
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
Arm Title
Home Hearing Screening Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Home Hearing Screening Test/Brief video
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Automated hearing test
Intervention Description
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
Intervention Name(s)
Pure-tone Screener test
Intervention Description
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
Intervention Name(s)
Digits-in-noise test
Intervention Description
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
Intervention Name(s)
No screening test
Intervention Description
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
Intervention Name(s)
Automated hearing test/Motivation video
Intervention Description
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
Intervention Name(s)
Pure-tone Screener/Motivation video
Intervention Description
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
Intervention Name(s)
Digits-in-noise test/Motivational video
Intervention Description
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
Intervention Name(s)
No screening test/Motivational video
Intervention Description
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
Intervention Name(s)
Home Hearing Screening Test
Intervention Description
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
Intervention Name(s)
Home Hearing Screening Test/Brief video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Record number of participants who sought hearing healthcare 6 months after the initial visit.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Record number of participants whose attitude about hearing health care has changed 6 months after the initial visit.
Time Frame
4 years
Other Pre-specified Outcome Measures:
Title
Record which hearing screening method was best at motivating subjects to pursue hearing healthcare.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin P Feeney, Ph.D.
Organizational Affiliation
Portland VA Medical Center, National Center for Rehabilitative Auditory Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bay Pines VAHCS
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33844
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Portland VA Medical Center, National Center for Rehabilitative Auditory Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Community-Based Kiosks for Hearing Screening and Education

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