NCT01963104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,048

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

5.8 years

First QC Date

September 12, 2013

Last Update Submit

November 22, 2019

Conditions

Keywords

hearing test, audiology, healthcare utilization,patient education, hearing screening

Outcome Measures

Primary Outcomes (1)

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

    4 years

Secondary Outcomes (1)

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

    4 years

Other Outcomes (1)

  • Record which hearing screening method was best at motivating subjects to pursue hearing healthcare.

    4 years

Study Arms (10)

Automated hearing test

EXPERIMENTAL

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

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.

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.

Procedure: Digits-in-noise test

No screening test

EXPERIMENTAL

This group of subjects will not receive a screening test.

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.

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.

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.

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

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.

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.

Procedure: Home Hearing Screening Test/Brief video

Interventions

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.

Automated hearing 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.

Pure-tone Screener 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.

Digits-in-noise 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.

No screening 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. 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.

Automated hearing test/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.

Pure-tone Screener/Motivation 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.

Digits-in-noise 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.

No screening test/Motivational 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). 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

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.

Home Hearing Screening Test/Brief video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bay Pines VAHCS

Bay Pines, Florida, 33844, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Portland VA Medical Center, National Center for Rehabilitative Auditory Research

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin P Feeney, Ph.D.

    Portland VA Medical Center, National Center for Rehabilitative Auditory Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of NCRAR

Study Record Dates

First Submitted

September 12, 2013

First Posted

October 16, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations