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Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening

Internet Auditory Rehabilitation: Innovative Follow-up to Adult Hearing Screening.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04122183
Enrollment
31
Registered
2019-10-10
Start date
2021-08-17
Completion date
2023-12-30
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Hearing Screening, Auditory Rehabilitation

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.

Interventions

OTHERiManage (my hearing loss)

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

Sponsors

William Demant Foundation (Formerly known as the Oticon Foundation)
CollaboratorUNKNOWN
University of Louisville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Audiologist visit6 months following the failed hearing screeningThe percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.

Secondary

MeasureTime frameDescription
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 healthcareBaseline (within one week of screening) and 6 months post baselineMean score (which can range between 1 and 11) on each of 6 scales: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, perceived self-efficacy, and cues to action. A higher score indicates greater agreement with the construct.
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.Baseline, 4 weeks post baseline, and 6 months post baselineParticipants will select the statement that best describes their view of their hearing status, 1 indicates precontemplation, 2 indicates contemplation, 3 indicates, preparation, 4 indicates action on the Transtheoretical Model Continuum.
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.Baseline, and 6 months post baselineTotal score can range between 7 and 49, with a higher score indicating greater support from others.

Other

MeasureTime frameDescription
Program uptake3 months following the failed hearing screeningPercentage of experimental participants who begin the iManage program
Program completion3 months following the failed hearing screeningPercentage of experimental participants who complete the iManage program
Mean scores on the Audiology Decision Making Scale, a scale designed to measure preparedness for decision making for 13 specific decision processes4 weeks after completion of iManage ProgramMean score can range between 1 and 5 with higher scores indicating greater self-perceived usefulness of the iManage Program in making a decision about hearing healthcare.
A focus group of individuals who completed the iManage program to learn participants perceptions about the content, benefits and drawbacks of the iManage program6 to 8 weeks after completion of iManage ProgramQualitative thematic analysis will indicate common attitudes (themes) about the iManage program

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026