Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening

NCT04122183 | Completed

• 1 other identifier: 15.0663
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Hearing Screening, Auditory Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Audiologist visit

  The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.

  6 months following the failed hearing screening

Secondary Outcomes (3)

• 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

  Baseline (within one week of screening) and 6 months post baseline

• 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 baseline

• 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 baseline

Other Outcomes (4)

• Program uptake

  3 months following the failed hearing screening

• Program completion

  3 months following the failed hearing screening

• Mean scores on the Audiology Decision Making Scale, a scale designed to measure preparedness for decision making for 13 specific decision processes

  4 weeks after completion of iManage Program

Study Arms (2)

Program Group

EXPERIMENTAL

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.

Other: iManage (my hearing loss)

Delayed Program Group

NO INTERVENTION

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.

Interventions

iManage (my hearing loss) OTHER

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

Program Group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Experience seeing an audiologist for a hearing evaluation or management
• Experience using a hearing aid

Sponsors & Collaborators

• University of Louisville: lead
• William Demant Foundation (Formerly known as the Oticon Foundation): collaborator

Study Sites (1)

University of Louisville, Program in Audiology

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Galloway, AuD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: August 17, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)