Hearing Aid Education and Adaptation System

May 12, 2020 updated by: Healthcare Technologies and Methods, LLC

Interactive Technology for Hearing Aid Education and Acceptance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32605
        • Clear Sound Audiology
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Potomac Audiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TELLYHealth Group
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
Educational videos and questions.
No Intervention: Standard of Care Group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Handicap Inventory for the Elderly (HHIE)
Time Frame: 8-12 weeks
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)
Time Frame: 8-12 weeks
Pre-post changes in the CSOA communication strategies & attitudes scores
8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthcare Technologies and Methods, LLC

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Alan M Letzt, M.S., Healthcare Technologies and Methods, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2018

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTM092016
  • R44AG045947 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Aggregated data on hearing aid education will be shared.

IPD Sharing Time Frame

The date will be available approximately May 2025 for one year.

IPD Sharing Access Criteria

The criteria will be based on the policies of the selected data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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