Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening

NCT ID: NCT04122183

Last Updated: 2024-07-29

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-17

Study Completion Date

2023-12-30

Brief Summary

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The purpose of this study is to see if a newly developed program called "I Manage my hearing loss" (iManage) will increase the number of individuals who visit an audiologist after failing a hearing screening. The iManage program will educate individuals about hearing loss, demonstrate that hearing problems are important, demonstrate that support from family and friends is important and help participants identify the benefits and concerns related to seeking help for hearing loss.

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Program Group

Following a failed hearing screening, participants will be offered the standard of care (information sheet recommending a comprehensive hearing evaluation) and asked to complete the iManage Program. Six months after the screening participants will be asked if they visited an audiologist.

Group Type EXPERIMENTAL

iManage (my hearing loss)

Intervention Type OTHER

An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist.

Delayed Program Group

Following a failed hearing screening, participants will be offered the standard of care (information sheet recommending a comprehensive hearing evaluation). Six months after the screening participants will be asked if they visited an audiologist and they will be given the opportunity to complete the iManage Program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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iManage (my hearing loss)

An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject must fail a hearing screening (any threshold \>34 decibels hearing level at 2000 or 3000 Hertz in either ear) or show equivalent or greater degree of hearing loss on most recent audiogram.
* Free of obvious outer or middle ear disease (as measured by otoscopy)
* Between the ages of 45 and 85
* Pass a health literacy screening
* Pass a thinking skills screening

Exclusion Criteria

* Experience seeing an audiologist for a hearing evaluation or management
* Experience using a hearing aid
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Demant Foundation (Formerly known as the Oticon Foundation)

UNKNOWN

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Laura N. Galloway

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Galloway, AuD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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University of Louisville, Program in Audiology

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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15.0663

Identifier Type: -

Identifier Source: org_study_id

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