Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04122183
• Other study ID #: 15.0663
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: March 31, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Other:
• iManage (my hearing loss)
An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist.

Locations

Country	Name	City	State
United States	University of Louisville, Program in Audiology	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	William Demant Foundation (Formerly known as the Oticon Foundation)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program uptake	Percentage of experimental participants who begin the iManage program	3 months following the failed hearing screening
Other	Program completion	Percentage of experimental participants who complete the iManage program	3 months following the failed hearing screening
Other	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
Other	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
Primary	Audiologist visit	The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.	6 months following the failed hearing screening
Secondary	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
Secondary	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
Secondary	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