Clinical trial NCT04122183: Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening
Official title: Internet Auditory Rehabilitation: Innovative Follow-up to Adult Hearing Screening.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing Screening, Auditory Rehabilitation
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: William Demant Foundation (Formerly known as the Oticon Foundation)
First posted: 2019-10-10
Enrollment: 31
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Audiologist visit
timeFrame: 6 months following the failed hearing screening
Secondary outcomes:
measure: Change on the Health Belief Questionnaire, a survey that measures attitudes about the 6 constructs of the Health Belief Model as related to seeking hearing healthcare
timeFrame: Baseline (within one week of screening) and 6 months post baseline
measure: Change on the Readiness for Change Questionnaire, a single-item questionnaire that attempts to place the participant on a continuum regarding readiness for hearing healthcare as outline by the Transtheoretical Model.
timeFrame: Baseline, 4 weeks post baseline, and 6 months post baseline
measure: Total score on the Hearing Loss Support Scale, a questionnaire that measures self-perceived informational and emotional support from family, peers, and healthcare providers about managing hearing loss.
timeFrame: Baseline, and 6 months post baseline
Other outcomes:
measure: Program uptake
timeFrame: 3 months following the failed hearing screening
measure: Program completion
timeFrame: 3 months following the failed hearing screening
measure: Mean scores on the Audiology Decision Making Scale, a scale designed to measure preparedness for decision making for 13 specific decision processes
timeFrame: 4 weeks after completion of iManage Program
measure: A focus group of individuals who completed the iManage program to learn participants perceptions about the content, benefits and drawbacks of the iManage program
timeFrame: 6 to 8 weeks after completion of iManage Program
Locations:
city: Louisville
country: United States
facility: University of Louisville, Program in Audiology
state: Kentucky
Study officials:
affiliation: Professor
name: Laura Galloway, AuD
role: PRINCIPAL_INVESTIGATOR
References: