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Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122183
Recruitment Status : Suspended (Subject contact has been suspended until it is safe to screen hearing and participants feel safe seeing clinicians.)
First Posted : October 10, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
William Demant Foundation (Formerly known as the Oticon Foundation)
Information provided by (Responsible Party):
Jill Preminger, University of Louisville

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Other: iManage (my hearing loss) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet Auditory Rehabilitation: Innovative Follow-up to Adult Hearing Screening.
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Audiologist visit [ Time Frame: 6 months following the failed hearing screening ]
    The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline (within one week of screening) and 6 months post baseline ]
    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.

  2. 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. [ Time Frame: Baseline, 4 weeks post baseline, and 6 months post baseline ]
    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.

  3. 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. [ Time Frame: Baseline, and 6 months post baseline ]
    Total score can range between 7 and 49, with a higher score indicating greater support from others.


Other Outcome Measures:
  1. Program uptake [ Time Frame: 3 months following the failed hearing screening ]
    Percentage of experimental participants who begin the iManage program

  2. Program completion [ Time Frame: 3 months following the failed hearing screening ]
    Percentage of experimental participants who complete the iManage program

  3. Mean scores on the Audiology Decision Making Scale, a scale designed to measure preparedness for decision making for 13 specific decision processes [ Time Frame: 4 weeks after completion of iManage Program ]
    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. A focus group of individuals who completed the iManage program to learn participants perceptions about the content, benefits and drawbacks of the iManage program [ Time Frame: 6 to 8 weeks after completion of iManage Program ]
    Qualitative thematic analysis will indicate common attitudes (themes) about the iManage program



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122183


Locations
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United States, Kentucky
University of Louisville, Program in Audiology
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
William Demant Foundation (Formerly known as the Oticon Foundation)
Investigators
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Principal Investigator: Jill Preminger, PhD Professor
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Responsible Party: Jill Preminger, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT04122183    
Other Study ID Numbers: 15.0663
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no individual participant data (IPD) sharing plan at this time as this is a feasibility study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill Preminger, University of Louisville:
Hearing Screening, Auditory Rehabilitation
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases