Hearing LossNCT01963104
Community-Based Kiosks for Hearing Screening and Education
A study testing Automated hearing test, Pure-tone Screener test and Digits-in-noise test in people with Hearing Loss, run by Portland VA Medical Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Automated hearing test, Pure-tone Screener test and Digits-in-noise test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,048 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2013to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Some subjects will have a complaint of hearing difficulty without a recent hearing evaluation
Who cannot join
- For all groups: minimum age 18 years. No current hearing aid use
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bay Pines VAHCS
Bay Pines, Florida, 33844
Ohio State University
Columbus, Ohio, 43210
University of Minnesota
Minneapolis, Minnesota, 55455
Portland VA Medical Center, National Center for Rehabilitative Auditory Research
Portland, Oregon, 97239
About this study
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.
- Conditions
- Hearing Loss
- Being tested
- Automated hearing test, Pure-tone Screener test, Digits-in-noise test, No screening test, Automated hearing test/Motivation video
- Keywords
- hearing test, audiology, healthcare utilization,, patient education, hearing screening
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated hearing testProcedure or surgery
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 testProcedure or surgery
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 testProcedure or surgery
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 testProcedure or surgery
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 videoProcedure or surgery
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 videoProcedure or surgery
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 videoProcedure or surgery
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 videoProcedure or surgery
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 TestProcedure or surgery
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 videoProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Automated hearing test | Experimental | Subjects will take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up. Receives: Procedure: Automated hearing test |
| Pure-tone Screener test | Experimental | Subjects will take a pure-tone hearing screening test and then receive recommendations for hearing healthcare follow-up. Receives: Procedure: Pure-tone Screener test |
| Digits-in-noise test | Experimental | Subjects will take a digits-in-noise test and then receive recommendations for hearing healthcare follow-up. Receives: Procedure: Digits-in-noise test |
| No screening test | Experimental | This group of subjects will not receive a screening test. Receives: Procedure: No screening test |
| Automated hearing test/Motivation video | Experimental | 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. Receives: Procedure: Automated hearing test/Motivation video |
| Pure-tone Screener/Motivation video | Experimental | 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. Receives: Procedure: Pure-tone Screener/Motivation video |
| Digits-in-noise test/Motivational video | Experimental | 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. Receives: Procedure: Digits-in-noise test/Motivational video |
| No screening test/Motivational video | Experimental | 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 Receives: Procedure: No screening test/Motivational video |
| Home Hearing Screening Test | Experimental | 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. Receives: Procedure: Home Hearing Screening Test |
| Home Hearing Screening Test/Brief video | Experimental | 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. Receives: Procedure: Home Hearing Screening Test/Brief video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record number of participants who sought hearing healthcare 6 months after the initial visit.
Measured: 4 years
Secondary outcomes (1)
Record number of participants whose attitude about hearing health care has changed 6 months after the initial visit.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, M. Patrick Feeney, Portland VA Medical Center
- Investigators
- Martin P Feeney, Ph.D., Principal investigator, Portland VA Medical Center, National Center for Rehabilitative Auditory Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963104
- Sponsor's protocol ID
- 4R33DC011769-02
- Status last verified
- Nov 2019
- First submitted
- 12 Sep 2013
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Kiosks for Hearing Screening and Education
- ClinicalTrials.gov ID
- NCT01963104
- Acronym / sponsor ID
- 4R33DC011769-02
- Conditions
- Hearing Loss
- Keywords
- hearing test, audiology, healthcare utilization,, patient education, hearing screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,048 participants (actual)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Study start
- Sep 2013
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Automated hearing test | Experimental | Procedure: Automated hearing testSubjects will take an abbreviated automated hearing test and then receive recommendations for hearing healthcare follow-up. |
| Pure-tone Screener test | Experimental | Procedure: Pure-tone Screener testSubjects will take a pure-tone hearing screening test and then receive recommendations for hearing healthcare follow-up. |
| Digits-in-noise test | Experimental | Procedure: Digits-in-noise testSubjects will take a digits-in-noise test and then receive recommendations for hearing healthcare follow-up. |
| No screening test | Experimental | Procedure: No screening testThis group of subjects will not receive a screening test. |
| Automated hearing test/Motivation video | Experimental | Procedure: Automated hearing test/Motivation videoSubjects 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. |
| Pure-tone Screener/Motivation video | Experimental | Procedure: Pure-tone Screener/Motivation videoSubjects 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. |
| Digits-in-noise test/Motivational video | Experimental | Procedure: Digits-in-noise test/Motivational videoSubjects 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. |
| No screening test/Motivational video | Experimental | Procedure: No screening test/Motivational videoThis 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 |
| Home Hearing Screening Test | Experimental | Procedure: Home Hearing Screening TestSubjects 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. |
| Home Hearing Screening Test/Brief video | Experimental | Procedure: Home Hearing Screening Test/Brief videoSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Some subjects will have a complaint of hearing difficulty without a recent hearing evaluation
Key exclusion criteria (1 listed)
- For all groups: minimum age 18 years. No current hearing aid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated hearing testSubjects 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. | Procedure or surgery | Automated hearing test |
| Pure-tone Screener testDuring 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. | Procedure or surgery | Pure-tone Screener test |
| Digits-in-noise testDuring 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. | Procedure or surgery | Digits-in-noise test |
| No screening testThis 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. | Procedure or surgery | No screening test |
| Automated hearing test/Motivation videoSubjects 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. | Procedure or surgery | Automated hearing test/Motivation video |
| Pure-tone Screener/Motivation videoDuring 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. | Procedure or surgery | Pure-tone Screener/Motivation video |
| Digits-in-noise test/Motivational videoDuring 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. | Procedure or surgery | Digits-in-noise test/Motivational video |
| No screening test/Motivational videoThis 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. | Procedure or surgery | No screening test/Motivational video |
| Home Hearing Screening TestSubjects 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. | Procedure or surgery | Home Hearing Screening Test |
| Home Hearing Screening Test/Brief videoSubjects 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. | Procedure or surgery | Home Hearing Screening Test/Brief video |
Primary outcome
Record number of participants who sought hearing healthcare 6 months after the initial visit.
Time frame: 4 years
1 secondary outcome
Record number of participants whose attitude about hearing health care has changed 6 months after the initial visit.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin P Feeney, Ph.D. principal investigator
Portland VA Medical Center, National Center for Rehabilitative Auditory Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated hearing test, Pure-tone Screener test and Digits-in-noise test in people with Hearing Loss, run by Portland VA Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record number of participants who sought hearing healthcare 6 months after the initial visit. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019; AzTrials last refreshed its copy on 1 Nov 2026.