Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening

Study Overview
=================
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.

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

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Other: iManage (my hearing loss)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Program Group<br>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)<br>* An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist.<br>|
| No Intervention: Delayed Program Group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audiologist visit | The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation. | 6 months following the failed hearing screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hearing Screening, Auditory Rehabilitation