Hearing Aid Education and Adaptation System

Study Overview
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Brief Summary
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This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Subjects in each group will complete questionnaires at enrollment, mid-study and at the end of the study.

Detailed Description
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HTM will develop the TELLYHealth (tm) system that will provide education on hearing aid use and maintenance. HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealth to patients and audiologists including: reductions in hearing handicap, improved knowledge of hearing aid handling, use and communications strategies; and improved audiologist aftercare. The investigators will recruit 80 subjects (half in each group) and each subject will participate in the study for 8-12 weeks.

Official Title
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Interactive Technology for Hearing Aid Education and Acceptance

Conditions
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Hearing Loss

Intervention / Treatment
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* Other: TELLYHealth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Speaks and reads English fluently Has mild (25-40 dB) to severe (70-95 dB) monaural sensorineural hearing loss Will be fitted with one or two hearing aids at the time of enrollment Owns a standard TV Has Internet access at home Has sufficient corrected vision to watch videos and read text on the TV and mobile device No signs of dementia Exclusion Criteria: Lives with person who has enrolled in the study

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TELLYHealth Group<br>Subjects will receive the standard of care in hearing aid education and the TELLYHealth intervention for use over an 8 to12-week period and will be followed by their audiologist for 8 to 12 weeks. | Other: TELLYHealth<br>* Educational videos and questions.<br>|
| No Intervention: Standard of Care Group<br>Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing Handicap Inventory for the Elderly (HHIE) | Pre-post changes in the HHIE total scores | 8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication Scale for Older Adults (CSOA) | Pre-post changes in the CSOA communication strategies & attitudes scores | 8-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing loss, Presbycusis, Aging, Teleaudiology