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Completed

NCT Number: NCT04122183

Internet Auditory Rehabilitation: 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.

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Key information

Conditions

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

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville, Program in Audiology

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iManage (my hearing loss)

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • William Demant Foundation (Formerly known as the Oticon Foundation)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2019
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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