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
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Other: iManage (my hearing loss)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Audiologist visit [ Time Frame: 6 months following the failed hearing screening ]The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.
- 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.
- 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.
- 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.
- Program uptake [ Time Frame: 3 months following the failed hearing screening ]Percentage of experimental participants who begin the iManage program
- Program completion [ Time Frame: 3 months following the failed hearing screening ]Percentage of experimental participants who complete the iManage program
- 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.
- 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
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
|United States, Kentucky|
|University of Louisville, Program in Audiology|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Jill Preminger, PhD||Professor|