Hearing Aid Education and Adaptation System

Hearing Loss Clinical Trial

Official title:

Interactive Technology for Hearing Aid Education and Acceptance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839759
• Other study ID #: HTM092016
• Secondary ID: R44AG045947
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Healthcare Technologies and Methods, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• TELLYHealth
Educational videos and questions.

Locations

Country	Name	City	State
United States	Clear Sound Audiology	Gainesville	Florida
United States	Potomac Audiology	Rockville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Healthcare Technologies and Methods, LLC	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing Handicap Inventory for the Elderly (HHIE)	Pre-post changes in the HHIE total scores	8-12 weeks
Secondary	Communication Scale for Older Adults (CSOA)	Pre-post changes in the CSOA communication strategies & attitudes scores	8-12 weeks