Back to resultsInternet Auditory Rehabilitation: Follow-up to Adult Hearing Screening
Primary Purpose
Hearing Loss
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iManage (my hearing loss)
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Screening, Auditory Rehabilitation
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
Sites / Locations
- University of Louisville, Program in Audiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Program Group
Delayed Program Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Audiologist visit
The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04122183
First Posted
October 8, 2019
Last Updated
September 25, 2023
Sponsor
University of Louisville
Collaborators
William Demant Foundation (Formerly known as the Oticon Foundation)
1. Study Identification
Unique Protocol Identification Number
NCT04122183
Brief Title
Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening
Official Title
Internet Auditory Rehabilitation: Innovative Follow-up to Adult Hearing Screening.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
William Demant Foundation (Formerly known as the Oticon Foundation)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing Screening, Auditory Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Program Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Program Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
iManage (my hearing loss)
Intervention Description
An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist.
Primary Outcome Measure Information:
Title
Audiologist visit
Description
The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.
Time Frame
6 months following the failed hearing screening
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline (within one week of screening) and 6 months post baseline
Title
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.
Description
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.
Time Frame
Baseline, 4 weeks post baseline, and 6 months post baseline
Title
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.
Description
Total score can range between 7 and 49, with a higher score indicating greater support from others.
Time Frame
Baseline, and 6 months post baseline
Other Pre-specified Outcome Measures:
Title
Program uptake
Description
Percentage of experimental participants who begin the iManage program
Time Frame
3 months following the failed hearing screening
Title
Program completion
Description
Percentage of experimental participants who complete the iManage program
Time Frame
3 months following the failed hearing screening
Title
Mean scores on the Audiology Decision Making Scale, a scale designed to measure preparedness for decision making for 13 specific decision processes
Description
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.
Time Frame
4 weeks after completion of iManage Program
Title
A focus group of individuals who completed the iManage program to learn participants perceptions about the content, benefits and drawbacks of the iManage program
Description
Qualitative thematic analysis will indicate common attitudes (themes) about the iManage program
Time Frame
6 to 8 weeks after completion of iManage Program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Galloway, AuD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville, Program in Audiology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no individual participant data (IPD) sharing plan at this time as this is a feasibility study.
Learn more about this trial
Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening
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