Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Other: iManage (my hearing loss)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, Program in Audiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: iManage (my hearing loss); An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Audiologist visit	The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.	6 months following the failed hearing screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Mean 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.	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.	Participants 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.	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.	Total score can range between 7 and 49, with a higher score indicating greater support from others.	Baseline, and 6 months post baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program uptake	Percentage of experimental participants who begin the iManage program	3 months following the failed hearing screening
Program completion	Percentage of experimental participants who complete the iManage program	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	Mean 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.	4 weeks after completion of iManage Program
A focus group of individuals who completed the iManage program to learn participants perceptions about the content, benefits and drawbacks of the iManage program	Qualitative thematic analysis will indicate common attitudes (themes) about the iManage program	6 to 8 weeks after completion of iManage Program

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: William Demant Foundation (Formerly known as the Oticon Foundation)
• Investigators: Principal Investigator: Laura Galloway, AuD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Hearing Screening, Auditory Rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 15.0663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no individual participant data (IPD) sharing plan at this time as this is a feasibility study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No